Bringing you the latest guidance medicines regulations
In the fast-paced world of medicines regulations, our team keeps a close eye on the latest updates and guidance from the regulators. This page serves as a portal for some of the highlights and key guidance, whilst our monthly Regulatory Intelligence Digest pulls together monthly regulatory updates that can be delivered straight into your inbox. You can sign up for this free service on this page, and follow us on LinkedIn @boyds or Twitter @boydconsultants to keep up to date with the latest guidance and advice.
If you would like to speak to a member of our regulatory team, feel free to get in touch and we will be happy to help.
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Latest Regulatory Updates
FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval
The U.S. Food and Drug Administration issued draft guidance aimed at improving oncology clinical trials for accelerated approval – Clinical Trial Considerations To Support Accelerated Approval of Oncology Therapeutics; Draft Guidance for Industry; Availability.
“The accelerated approval pathway is commonly used for the approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.”
MHRA publish their response to the consultation on the clinical trials regulation
MHRA has announced a series of measures aimed at streamlining clinical trials approvals in the UK. The new framework will create a more streamlined and flexible application process for clinical trials, without compromising on safety.
The legislative changes to the clinical trial approvals framework will:
- Ensure patients and their safety remain at the focus of all clinical trials and bring the benefits of clinical trials to everyone.
- Create a proportionate and flexible regulatory environment.
- Cement the UK as a destination for international trials.
- Provide a framework that is streamlined, agile and responsive to innovation.
Access the press release here.
Access the report here.
FDA Issues Draft Guidance on the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
The FDA has issued draft guidance for industry on Optimising the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.
This applies to small molecules and biologics in development for use in oncology, and ties in with the FDA’s Oncology Center of Excellence (OCE) Project Optimus which was launched in May last year and which set out the FDA’s thinking on dose optimisation for oncology drugs (the aim being to shift away from simply identifying the maximum tolerated dose in trials to identification of a dose that is still efficacious but optimally tolerated).
FDA Issues Draft Guidance for Industry on use of Real-World Data
The FDA has issued draft guidance for industry on recommendations for the use of real-world data and real-world evidence to support regulatory decision-making for drugs and biological products.
The U.S. Food and Drug Administration issued a draft guidance for industry titled ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products’. The guidance discusses the applicability of FDA’s investigational new drug (IND) application regulations under 21 CFR part 312 to clinical study designs that use real-world data (RWD) and clarifies the agency’s expectations for sponsors submitting new drug applications using RWD to support the safety or effectiveness of a drug in clinical studies that are not subject to 21 CFR part 312.
Click here to view draft guidance document.
MHRA launches public consultation on future of medical device regulation
The MHRA has issued a press release regarding the public consultation on the future of medical device regulation, encouraging people to contribute their views and changes to how medical devices will be regulated across the UK. The 10-week consultation gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework, and therefore patient safety in the future.
EMA: CTIS Highlights Newsletter
The EMA has issued its latest CTIS Highlights newsletter which provides an update on the ‘go-live’ date in January 2022, as well as an update on training and details on how to register for CTIS. The CTIS aims to harmonise the clinical trial regulatory submission processes in the EU and EEA. To read the newsletter in full, click here.
Combined review to facilitate speedier set up for clinical research trials
From January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK will be subject to a combined review from the MHRA and the UK Research Ethics Services, in collaboration with the Health Research Authority (HRA), facilitating rapid start-up and benefitting patients sooner.
Applicants need only make a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion and approval is delivered together. A number of sponsors have already used this new process with some reporting a 30 percent improvement in overall trial setup times.
ICH Webinar
The ICH Management Committee is taking the unique step to provide a status update on the revisions to the guideline “International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision”, via a public virtual conference on 18 and 19 May 2021.
The ICH E6 guideline for good clinical practice is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee will provide a status update on the revisions to this guideline.
Read more here. The Agenda is available here. Register for the meeting here.
Applicants need only make a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion and approval is delivered together. A number of sponsors have already used this new process with some reporting a 30 percent improvement in overall trial setup times.
Regulatory Factsheets
Follow the links below to download the factsheet.
- Orphan Drug Designation (EU & UK)
- Orphan Drug Designation (US)
- The Clinical Trials Regulation and the Clinical Trials Information System
- Preparing for the Clinical Trials Regulation (CTR)
- Scientific Advice US-FDA
- Regulation of Medical and In Vitro Diagnostic Medical Devices in the UK
- Clinical Trials with Genetically Modified Organisms (EU)
Regulatory Affairs Digest
Below are links to recent issues of our monthly Regulatory Affairs Digest. To sign up and receive these direct to your inbox, click the sign-up button above and complete the form.
