Clinical trial regulation in 2026 is the set of rules that tell sponsors, sites, and supply teams how to plan, run, and document studies with people in a safe and ethical way. It brings together ICH-GCP as the global good clinical practice standard, EU Clinical Trials Regulation 536/2014, UK rules, FDA 21 CFR 312 in the US, and extra local laws. In daily work this means clear informed consent in clinical trials, strong data integrity in clinical trials, safe investigational medicinal product handling, and complete records so inspectors can see what happened from protocol to patient.
• Clear rules protect patient rights, safety, and dignity and support reliable data for decisions on new treatments.
• Global clinical trial compliance combines ICH-GCP with EU, UK, US, and country rules that sponsors must map in one plan.
• Clinical trial regulation shapes daily tasks such as protocol design, monitoring, clinical trial documentation and audits, and IMP packaging and labelling.
• Strong processes for IMP manufacturing, storage, shipping, and returns are central parts of clinical trial supply chain regulation.
• Specialist packaging partners help translate rules into safe, easy to use, and compliant trial kits for patients and sites.
Why clinical trial regulation exists
Clinical trial regulation exists to protect people who take part in studies and to make sure that trial data are good enough for health authority decisions. Rules give a clear structure for how to inform participants, how to manage risks, how to monitor safety, and how to record every important step. Because of this, regulators can see if a study respected human rights and scientific quality when they review results or inspect a sponsor or site.
What a clinical trial is in simple terms
A clinical trial is a planned study in people to test a medicine, vaccine, device, or a new way to use an existing treatment. The study follows a protocol, which is a written plan. The protocol explains who can join, what treatment they get, what visits and tests are needed, and how long the trial will last. The main goals are to learn about safety, dose, and effect. Because people take part, rules focus on patient safety in clinical research and on respect for the person.
The trial team must follow the protocol and also follow company procedures and local laws. If something changes, such as dose or visit schedule, they often need ethics and regulatory approval before they can apply the change. This is how authorities keep control over what happens to participants.
How rules protect people and data
Rules explain how to give information to participants, how to handle risks, and how to react if something goes wrong. For example, they describe how to obtain informed consent in clinical trials, when to report safety events, and how to stop a trial early if there is a major safety concern. At the same time, rules guide how to collect and store data so that results are accurate and can be checked later. This supports data integrity in clinical trials and helps prevent fraud or simple mistakes.
Ethics bodies, regulators, sponsors, and investigators all work inside this shared framework. Each group has its own role, but they all focus on keeping risks as low as possible while still answering the scientific question.
The global framework of clinical trial regulation
For any new trial, sponsors must look at two levels. The first is the global good clinical practice guideline ICH-GCP. The second is regional or national laws such as EU Clinical Trials Regulation 536/2014, UK frameworks after Brexit, and FDA 21 CFR 312 and related parts in the United States. Together these layers form the map for global clinical trial compliance and show which approvals, documents, and processes are needed.
ICH GCP as the common standard
ICH GCP, also called ICH E6, is the main global standard for ethics and quality. It explains how to design, run, record, and report trials so that rights of participants are protected and data are reliable. The current version is E6 R2 and a new version E6 R3 is in development. The newer text puts more attention on risk based quality management and on practical steps to protect data and people.
In daily work this means sponsors need formal risk assessments, proportionate monitoring plans, training for all staff, and strong vendor management. Systems must support traceable records, version control, and audit trails. Vendors such as laboratories, data management providers, and packaging sites must work under quality agreements. Sponsors stay responsible and must oversee this work through audits and regular reviews.
Regional and national laws in the EU, UK, and US
On top of ICH-GCP, each region sets its own rules. In the EU and EEA, EU Clinical Trials Regulation 536/2014 is the main law that governs drug trials. It introduced the CTIS clinical trials information system, which is the central portal for submissions and reporting. In the UK, national rules build on the previous EU directive, ICH-GCP, and UK specific guidance after Brexit, and changes continue over time. In the US, FDA 21 CFR 312 defines requirements for Investigational New Drug applications, while Parts 50 and 56 of 21 CFR cover protection of human subjects and institutional review boards.
Sponsors who run one global protocol across many regions must combine these requirements into a single operating plan. They need to align wording in the protocol, consent forms, case report forms, safety reports, and labels so that each country receives what is needed for its law.
Core pillars of clinical trial regulation
Across regions, rules share some common ideas. These pillars include informed consent, ethics review, risk benefit balance, safety reporting, data integrity and privacy, and clear sponsor and investigator responsibilities.
Informed consent in clinical trials
Informed consent is the process where a person receives clear information about a trial and then decides if they want to join. It is both a written form and a talk between the investigator and the potential participant. The form must explain the purpose of the study, what will happen, possible risks and benefits, other treatment options, and the right to stop at any time without punishment or loss of care. Language must be simple and neutral so that people really understand, and extra safeguards are needed for children and adults who do not have full capacity to consent.
Consent does not end with a signature. If new important information appears, such as a new risk, the site may need to inform participants again and ask them to sign an updated version. In decentralised models, electronic consent, or eConsent, can be used, but rules still expect personal explanation and a way for the person to ask questions.
Risk benefit assessment and ethics review
Before a study starts, the sponsor must show that the expected benefit is likely to be greater than the risk. This risk benefit assessment looks at non clinical data, earlier trials, the planned dose and route, and the target population. Clinical trial ethics committees in the EU and IRBs in the US review this information together with the protocol, consent forms, and recruitment materials. They can request changes or refuse approval if they see a problem with safety, scientific value, or participant rights.
Trials can start only when ethics and regulatory bodies agree that the design is acceptable. During the trial, they keep oversight through safety reports and updates and can stop or change a study if the balance shifts.
Safety reporting duties
Safety reporting rules describe how to collect and report events that harm or could harm participants. A serious adverse event is an event that leads to death, is life threatening, needs or extends hospital stay, causes disability, or is another important medical event. A suspected unexpected serious adverse reaction is a serious event that may be linked to the study drug and is not described in the current safety information. Sponsors must assess these events and send reports within strict timelines to regulators and ethics bodies.
Good pharmacovigilance in trials supports patient safety in clinical research. It also supports better decisions, for example about dose changes or stopping rules. Safety data feed into regular reviews, database cleaning, and signal detection activities.
Data integrity and privacy in practice
Data integrity in clinical trials means that data are accurate, complete, consistent, and traceable from source to final report. Every important entry in medical records, lab printouts, and electronic systems should be attributable to a person, readable, entered at the correct time, original or a true copy, and accurate. Systems need controls such as role based access and audit trails so that changes are visible. Training must explain why small habits such as signing and dating a note matter for inspections.
In the EU, data protection laws like GDPR work beside clinical trial regulation. They explain how to use coded (pseudonymised) data, who can see direct identifiers, how long data can be stored, and how to handle transfers outside the EU or EEA. Consent forms must explain how data will be used, shared, and protected so that participants understand what happens to their information.
EU Clinical Trials Regulation 536/2014 and CTIS
EU Clinical Trials Regulation 536/2014 is the main framework for drug trials in the EU and EEA. It replaced the old Clinical Trials Directive to give faster and more consistent approvals and to increase transparency. The regulation introduced the CTIS clinical trials information system as a single entry point for sponsors and authorities.
Main goals and scope of the EU rules
The key goals of the EU rules are harmonised authorisation and supervision across Member States, a single electronic submission through CTIS, and more public information about trials. The regulation covers most interventional drug trials and describes how to apply for approval, how to run trials, and what to report during and after the study. It also includes specific chapters on safety reporting, monitoring, inspections, and investigational medicinal product management.
Because guidance and Q and A documents are updated over time, sponsors should always check the latest EMA and national information before they prepare a new application or submit a change.
How CTIS clinical trials information system works for sponsors
CTIS is the portal that sponsors use to manage trials in the EU and EEA. Through CTIS, the sponsor sends one application that lists all Member States where they want to run the trial. The dossier has a scientific part that includes the protocol, investigator brochure, and IMP data. It also has a part that covers ethics and local topics such as recruitment and site information.
Member States share the assessment work so that one state often leads the review of the scientific part and others focus more on local aspects. Sponsors then use CTIS to submit substantial amendments, safety reports that require regulator attention, end of trial notices, and summary results including a lay summary for the public.
Steps to get and keep approval under CTR
In simple terms, sponsors first plan and compile the dossier, then submit it through CTIS. They receive requests for information from Member States and must answer within set timelines. After this they receive one decision per country. Once the trial is authorised, sponsors must keep the approvals up to date by reporting substantial amendments, annual safety reports, temporary halts, and trial end. They also prepare and upload the summary of results within the required timeframe.
From an operational view, this means teams need a clear calendar of deadlines and responsibilities. Regulatory, clinical, pharmacovigilance, and supply colleagues must work together to keep CTIS information aligned with the real conduct of the study.
FDA 21 CFR 312 and other US clinical trial regulation basics
In the United States, trials with drugs and biologics follow US law and FDA rules. These focus on participant protection, sound science, and clear sponsor and investigator responsibilities.
When an IND is needed and what it contains
Most drug and biologic trials in the US need an approved Investigational New Drug application before they start. FDA 21 CFR 312 explains when an IND is required and which information must be in the file. An IND includes quality information about how the drug is made, data from animal and early human studies, the study protocol, investigator information, and a plan for monitoring and safety reporting. The FDA has 30 days to review a new IND and can put the study on hold if it sees safety or design issues.
After a trial starts, sponsors must send regular safety updates and annual reports. They must inform FDA about significant protocol changes, new safety concerns, and new studies that use the same IMP.
Roles of Parts 50 and 56 for ethics and IRBs
Two other important sets of US rules are 21 CFR Part 50 on protection of human subjects and 21 CFR Part 56 on institutional review boards. Part 50 describes in detail what information must be in consent forms and how to protect vulnerable groups. Part 56 explains how IRBs are built, how they work, and how often they must review each study.
Before a US site can start enrolment, an IRB must approve the protocol, consent forms, and any recruitment materials. Investigators and sponsors must keep IRBs informed about changes, safety issues, and study progress. This supports independent ethics review over the whole life of the trial.
Roles and responsibilities under clinical trial regulation
Clinical trial regulation makes clear who is responsible for which tasks. The main roles are sponsor, investigator, ethics committees or IRBs, and regulators.
Sponsor responsibilities and oversight
The sponsor is the person or company that starts a trial and takes overall responsibility. Sponsor and investigator responsibilities are described in ICH GCP and in local laws. The sponsor writes and owns the protocol, selects qualified investigators and vendors, and sets up a quality system that covers risk assessment, monitoring, data management, and safety oversight. The sponsor must provide training and supporting documents to sites and must keep oversight of vendors such as CROs, labs, and packaging partners.
From a practical point of view, this includes clear contracts, defined performance indicators, regular meetings, and audits where needed. The sponsor also makes sure that IMP manufacturing and packaging follow Good Manufacturing Practice and that supply processes follow clinical trial supply chain regulation along the full chain from plant to site and back again.
Investigator responsibilities at the site
The investigator is usually a doctor or another qualified person who leads the trial at a site. They are responsible for the medical care of participants and for applying the protocol at that site. They must obtain informed consent, check that each participant meets eligibility criteria, manage study visits, and ensure accurate and timely data entry. They also report safety events to the sponsor and, where needed, to ethics bodies.
Investigators must maintain a complete site file that includes approvals, delegation logs, training records, correspondence, and IMP accountability. They work closely with monitors and auditors and must act on any findings and corrective actions.
Ethics committees, IRBs, and regulators
Ethics committees in the EU and IRBs in the US are independent groups that protect the rights, safety, and well being of participants. They review protocols, consent forms, investigator brochures, recruitment materials, and substantial amendments. They can require changes or refuse approval if they have concerns. Regulators such as EMA, national competent authorities, FDA, and MHRA are responsible for authorising trials, supervising conduct, and performing inspections.
All of these groups rely on sponsors and investigators to provide complete, correct, and timely information. Clear communication helps prevent delays and supports trust during inspections.
What clinical trial regulation means in daily study operations
For operations teams, clinical trial regulation affects many daily tasks. It shapes how the protocol is written, how sites are trained, how monitoring is planned, and how documentation is handled.
Protocol design, monitoring, and training
Regulatory expectations start at the protocol stage. A good protocol is based on risk assessment and contains clear endpoints and safety measures. It should be realistic for sites in all planned countries and should support safe and simple visit schedules. If the design is too complex, there is a higher risk of protocol deviations and data gaps. Monitoring plans and quality by design approaches then follow from this protocol.
Training plans must cover protocol content, ICH-GCP basics, local regulatory requirements, safety reporting, and IMP handling. Before first patient first visit, cross functional teams such as clinical, data management, pharmacovigilance, and supply should review together how these topics will work in practice.
Clinical trial documentation and audits
Clinical trial documentation and audits are central tools to show compliance. The trial master file at sponsor level and the investigator site file at each site must together tell the full story of how the trial was planned and conducted. They hold approvals, versions of protocols and consent forms, monitoring reports, safety communications, IMP records, and more. Many sponsors now use electronic systems, but the same expectations for completeness and traceability apply.
Auditors and inspectors use these files to test if processes matched written procedures and regulations. For teams, this means that every important decision or action should leave a trace in the file. Simple habits such as writing meeting minutes, tracking decisions, and filing emails help show good control later.
What to expect during an inspection
During a GCP inspection, regulators want to see if a trial followed ICH-GCP and local laws. They may visit sponsor offices, CROs, vendors such as IMP packagers, and sites. Inspectors review documents and systems, interview staff, and sometimes watch how processes work, for example how randomisation, unblinding, or IMP dispensing is done. They focus on areas such as informed consent, safety reporting, data integrity, IMP management, and vendor oversight.
After the inspection, regulators send a report that lists findings and classifies them by severity. The sponsor must respond with root cause analysis and a corrective and preventive action plan. Good preparation and honest, timely answers often help reduce impact on the trial and on future work.
Clinical trial regulation and the IMP supply chain
Rules also cover the full life cycle of the investigational medicinal product, from manufacturing and packaging through distribution to sites and then back for returns and destruction. Clinical trial supply chain regulation links GCP and GMP and affects daily tasks for technical, quality, and logistics teams.
IMP manufacturing, GMP, and investigational medicinal product (IMP) regulation
An investigational medicinal product is the study drug or placebo that participants receive. It can also be a reference product used for comparison. Investigational medicinal product (IMP) regulation connects GCP with Good Manufacturing Practice. IMPs must be made in GMP compliant facilities. These facilities need qualified equipment, validated processes, and clear batch records. In many regions, a manufacturing or import licence is required and a qualified person or similar role must certify each batch before release.
Even small changes in formula, manufacturing site, or critical process can trigger new stability work and regulatory updates. Operations teams should therefore agree change control steps that include regulatory, quality, and supply input before they change anything that may affect IMP quality or labelling.
Clinical trial packaging and labelling requirements
Clinical trial packaging and labelling requirements are a key part of IMP rules. Packaging must protect the product, keep it stable, and support correct use. Labels must include defined information such as product or code, trial code, batch number, expiry date, storage conditions, and a statement that the medicine is for clinical trial use. Blinded trials need packs that hide which treatment a participant receives and support randomisation and emergency unblinding.
Companies that package or label IMP usually need a manufacturing or related permit and must follow both GMP and GCP principles. This includes qualified lines, line clearance, label reconciliation, and control of waste. Good design and planning here reduce risk of packaging errors, wrong labels, or stock write off after protocol changes.
Storage, shipping, and destruction under global clinical trial compliance
Storage and shipping must follow the conditions defined in the application dossier and on the pack. This includes temperature, light, and humidity where needed. Many regions expect qualified shipping routes, temperature monitoring, and clear records of each shipment and each transfer between depots and sites. These expectations are part of global clinical trial compliance and link closely to quality and safety.
At the end of a trial, or when packs are damaged or expired, IMP must be returned or destroyed in a controlled way. Teams must reconcile quantities and keep documentation that connects batch, site, and patient codes. Poor reconciliation is a common finding in inspections and can raise questions about traceability and safety.
EU labelling rules under CTR for IMP packs
The EU CTR contains specific rules for labels on investigational medicinal products. Chapter X and Annex VI are the main sources for these requirements.
Key elements from Chapter X and Annex VI
Annex VI lists which items must appear on IMP labels. These include the trial code and protocol ID, the product name or code, the pharmaceutical form and strength, route of administration where relevant, batch number, expiry or use by date and sometimes a retest date, storage conditions, and a clear statement that the medicine is for clinical trial use only. Labels must also support identification of the subject and investigator site, often with coded information so that personal data stay protected.
There are some flexibilities for particular types of products or trials, so sponsors should always cross check the latest EMA and national guidance. Local notes can influence details such as language, font size, and layout.
Expiry dating, re labelling, and change control
Annex VI gives some flexibility for expiry updates when there are new stability data. In some cases central records can be used without full relabelling if certain conditions are met. However, any relabelling or restickering that does take place must follow strict change control. This includes planning, approvals, line clearance, updated documentation, and verification of new labels on packs.
Protocol amendments that change dosing or shelf life can have a big impact on operations. The sponsor may need to update regulatory files, produce new labels, repackage affected stock, ship updated packs to many countries, and retrain site staff on new instructions. Early impact assessment with packaging, stability, and supply experts helps reduce waste and avoid delays.
How specialised packaging partners support compliant trials
Many sponsors choose to work with specialised clinical packaging partners to handle complex designs and strict rules. These partners work under GMP, follow GCP principles that apply to their work, and stay within the protocol and ethics decisions defined by the sponsor.
Working with GMP compliant clinical packaging partners
Specialised packaging partners handle format design, component selection, line setup, and batch documentation within the approved framework for each study. They prepare work instructions based on the protocol, the randomisation plan, and the labelling rules of each region. Their records become part of the GMP and GCP documentation trail that inspectors review.
We operate in this regulated environment and focus on patient centric and compliant solutions for complex and high value treatments. For readers who want to see how such support looks in practice, it can help to read about practical clinical trial packaging support and how design and production choices work within GCP and regulatory expectations.
Translating rules into kit design and labels
Turning rules into kit design starts with the protocol and visit schedule. Packaging engineers consider dosing schemes, titration steps, randomisation, and temperature needs. They must also think about which packs go to which country and what local label content is needed. Labels must contain all mandatory elements and still be readable and clear for patients and site staff.
Tools such as booklet labels and wallet cards can help fit many languages and instructions on a small surface. In our work, we often help teams choose structures that reduce handling errors, support adherence, and allow efficient relabelling if stability data later change.
Packaging challenges, patient centric design, and adherence
Global studies create extra work for packaging teams. Good design supports both clinical trial regulation and daily use by patients, caregivers, and site staff so that medication errors and protocol deviations are less likely.
Multilingual labels, blinded kits, and changing shelf life
Multi country trials often need multilingual labels and booklets. Text must follow local wording rules and still be clear and simple. Blinded kits create extra tasks, for example managing randomisation codes, keeping blinding at the site pharmacy, and planning for safe emergency unblinding procedures. All of this must fit within regulatory rules and SOPs.
When shelf life changes, supply teams must know which packs at which sites carry which expiry date. They then decide whether to relabel or replace stock. Poor control in this area can lead to outdated packs at sites or rushed actions that increase risk. Strong planning and tracking systems reduce these risks and support inspections.
Child resistant, easy to use, and clear instructions
Patient centric design links closely to GCP aims because it supports safe and consistent use. Packs may need child resistant features to protect young children from access, but they should also be easy enough for older adults or people with limited hand strength to open. Clear dosing instructions, calendars, or visit reminders on or inside the pack can support adherence to the protocol.
Usability testing with people who are similar to the planned participant group can reveal issues before a trial starts. This may lead to design changes that reduce the risk of missed doses, double dosing, or mistakes with complex regimens.
Example of patient friendly and sustainable packaging
In one project, a wallet pack design helped patients follow a complex dosing pattern and reduced material use compared with an older design. Features such as a clear layout, obvious opening points, and step by step instructions supported correct use and easier handling at the site. Readers can see a real life case of patient focused, compliant packaging where usability and sustainability were both considered inside a strong quality framework.
Moving targets in clinical trial regulation
Regulatory frameworks are not static. New guidelines appear, existing ones are updated, and new models such as decentralised trials introduce fresh questions.
ICH GCP E6 R3 and risk based quality
The planned ICH GCP E6 R3 puts more focus on risk based quality management. This means studies should be designed so that the main risks to participants and to data are identified early and managed in a proportional way. It expects more use of central monitoring, data analytics, and quality tolerance limits so that teams can find and fix problems sooner.
Sponsors can prepare by reviewing draft texts, comparing them to their current SOPs, and planning updates to monitoring approaches, vendor oversight, and training. Early adaptation often reduces stress when new versions become effective.
Decentralised trials, eConsent, and digital tools
Decentralised and hybrid trials move some visits or data collection away from traditional sites. Examples include home nursing, direct to patient shipping of IMP, remote source data review, and eConsent solutions. These models can improve access and convenience, but they also bring questions about oversight, data flow, data privacy, and IMP control.
Study teams should map which trial activities will be remote and then check the latest guidance from EMA, FDA, MHRA, and relevant local authorities. They should work with IT, data protection, and supply experts so that technical tools and processes stay inside regulatory and security expectations.
Local country requirements and when to seek advice
On top of global and regional frameworks, each country can add specific rules. These may cover ethics procedures, bioethics laws, radiation or gene therapy, import and export licences, or extra safety reporting steps. Some countries also have fixed templates for patient information sheets or label text. Because of this, sponsors should build early contact with local affiliates or experienced CROs when they plan a multi country trial.
Complex studies, such as first in human or gene therapy trials, often require legal or specialist regulatory advice. This helps avoid surprises at ethics or authority review and reduces the risk of delays or major changes later in the study.
Turning rules into checklists for packaging and supply teams
Regulations can feel complex for packaging engineers and supply planners. Checklists and clear specifications turn these rules into daily tools that teams can follow and improve over time.
From protocol to packaging specification
For packaging and supply teams, the protocol is the main starting document. It explains arms, dosing schedules, visit windows, storage conditions, and what data need to be collected. From this, teams can build packaging concepts, kit lists, and bills of materials. They must also consider which countries will join and which clinical trial packaging and labelling requirements apply in each region.
A strong packaging specification links every protocol step to a concrete pack, label, or leaflet. It includes dimensions, components, carton text, booklet layout, and coding needs. This specification then guides tooling, line setup, qualification, and routine production. You can learn more about how we approach packaging design and development under strict regulatory expectations and how this supports safe and efficient trials.
Labelling, storage, and shipping checklists
Simple checklists help ensure that daily work stays aligned with regulations. A labelling checklist may include mandatory text per region, language and translation checks, blinding and randomisation codes, font size and contrast, and space for expiry updates. A storage checklist can cover temperature and light requirements, monitoring devices, alarm rules, and backup plans during power failures or equipment breakdowns.
Shipping checklists may include packaging qualification, courier selection, customs documentation, import permits, tracking needs, and temperature monitoring during transport. These lists should link to SOPs that describe what to do when something goes wrong, for example a temperature excursion or a shipment delay.
Returns, reconciliation, and destruction plans
End of life handling is an area where inspectors often find weaknesses. Before the trial starts, supply and quality teams should agree how sites will return unused or partially used IMP, how central warehouses will count and reconcile quantities, and how destruction will be arranged and documented. Plans should cover blinded and open label materials, damaged packs, and expired stock.
Clear instructions, forms, and system workflows help sites understand what to do and make it easier to show full traceability later. Good planning can also support sustainability in the pharmaceutical supply chain by reducing waste and avoiding unnecessary shipments while still meeting regulatory expectations.
Managing complexity with clear processes and the right partners
Clinical trial regulation touches many groups inside a company. Good coordination and the right support make it easier to work in a consistent and inspection ready way.
Building internal alignment across functions
No single person can hold all knowledge about clinical rules, supply, and protocol design. Clinical, regulatory, quality, pharmacovigilance, packaging, and logistics teams all contribute part of the picture. Regular cross functional meetings to review protocols, risk assessments, IMP plans, and labelling concepts help keep everyone aligned. Shared tools such as central risk logs or decision trackers make it easier to explain choices during inspections.
In our projects, we see that early contact between clinical operations and technical teams often prevents late design changes, expensive repackaging, or protocol deviations linked to unclear instructions on packs.
When to ask for expert packaging support
Specialist input can be helpful when designs are complex, when there are many languages, tight stability, frequent protocol amendments, or strict regional rules. Packaging experts work at the point where regulations, human factors, and technical limits meet. They can suggest designs that support good adherence, allow future relabelling, and still run efficiently on available lines.
Support is especially useful when moving from early phase, small batch packaging to larger phase 3 or commercial scale studies, or when adding new countries with different label rules to an ongoing trial.
Next steps if you need to discuss a specific trial
Clinical trial regulation is demanding, but it becomes manageable with clear processes, good documentation, and trained teams who understand their roles. Patient focused packaging and close collaboration between clinical, regulatory, QA, and supply colleagues help keep participants safe and studies robust. If you face detailed questions on how these rules affect a specific study or IMP, you can discuss your specific clinical packaging questions with experienced specialists and explore suitable options for your situation.
FAQ on regulation, IMP labelling, and inspections
What is the difference between ICH GCP and EU Clinical Trials Regulation 536/2014?
ICH GCP is a global guideline that sets ethical and quality principles for trials and is part of many regional rules. EU Clinical Trials Regulation 536/2014 is a binding EU law that explains how to apply these principles in the EU and EEA with concrete rules on submissions, assessments, safety reporting, transparency, and IMP labelling.
What must be on an IMP label in an EU clinical trial?
Under CTR Annex VI, an IMP label usually needs at least the trial code and protocol ID, product name or code, pharmaceutical form and strength, route of administration where needed, batch number, expiry or use by date, storage conditions, a clear statement for use in clinical trials only, and codes that can link the pack to the subject and site while keeping personal data protected.
How does FDA 21 CFR 312 affect sponsor responsibilities?
FDA 21 CFR 312 explains when an IND is required and what information must be submitted before a US trial starts. It also sets rules for ongoing sponsor responsibilities such as safety reporting, annual updates, and oversight of investigators and IRBs so that participants stay safe and data stay reliable.
What happens during a GCP inspection of clinical trial packaging and supply?
Inspectors review IMP manufacturing and packaging records, batch release and qualified person certification where relevant, distribution and temperature logs, and returns and destruction records. They check if packs and labels match approved versions, if reconciliation is complete, and if there is full traceability from protocol and randomisation through batch and site to patient codes.
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