Latest Regulatory Updates

January 2023

Hello and welcome back to the Boyds Regulatory Intelligence Digest. We are kicking off the new year with all the latest guidance and updates from the regulatory agencies - FDA, EMA, EC, EDQM, and HRA.

To discuss any of these updates please contact a member of the Boyds Regulatory team who will be happy to help.

Food and Drug Administration (FDA)

Final, Level 2 guidance released (revised version from guidance issued in July 2022): Failure to Respond to an abbreviated new drug application (ANDA) Complete Response Letter Within the Regulatory Timeframe Guidance for Industry

Provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a complete response letters (CRL), as well as the actions that FDA may take if the applicant fails to respond to that CRL.

Revision 1 to draft guidance: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

Defines the types of behaviours (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection.

Draft guidance released for public consultation: Content of Human Factors Information in Medical Device Marketing Submissions

The recommendations in this guidance are intended to promote consistency and facilitate efficient review of medical device submissions. Consultation ends 09 March 2023.

Approved drug labelling under Project Renewal

FDA approves updated drug labelling including new indications and dosing regimens for capecitabine tablets (Xeloda). Project Renewal, an Oncology Center of Excellence initiative aimed at updating labelling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the first drug to receive a labelling update under this pilot program.

First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer

FDA  approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

New HIV Drug for Adults with Limited Treatment Options

Sunlenca (lenacapavir), a new type of antiretroviral medication has been approved for adults living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1.

40th biosimilar approval in the US

FDA approved Idacio (adalimumab-aacf), a biosimilar for Humira (adalimumab), marking the 40th biosimilar approval in the U.S. Idacio is a tumor necrosis factor blocker indicated for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis and Plaque Psoriasis.

FDA 2021 Year in review

Report from Janet Woodcock, M.D., FDA's Acting Commissioner, highlighting FDA's work in 2021.

European Medicines Agency (EMA)

Facilitating Decentralised Clinical Trials in the EU

The European Commission (EC), Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) published recommendations to facilitate the conduct of decentralised clinical trials. For more information see Recommendation paper on decentralised elements in clinical trials and News & press release.

The paper addresses the roles and responsibilities of the sponsor and investigator, electronic informed consent, IMP delivery, trial related procedures at home, data management and monitoring in a decentralised clinical trial setting. An overview of the current national provisions applicable in each Member State is also included.

Revision adopted: ICH guideline E8 (R1) on general considerations for clinical studies, version 1 December 2022 contains minor corrections on page 21.

Update to Questions & Answers: Good Clinical Practice (GCP)

See revised Question 17: “How can sponsors demonstrate oversight for those activities that are delegated by written contract?”

Updated regulatory and procedural guideline: IRIS guide to registration and Research Product Identifiers (RPIs)

Updates to new version 2.11, 15 December 2022 include RPI and substance requests and access to IRIS.

Update to guide: Scientific Advice on medicines for Human use in the EU medicines regulatory network

Provides mapped information on current voluntary procedures available from EU regulators on Medicines for Human use; collated in the form of questions & answers.

EMA seeks feedback on draft Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances

The paper provides guidance on the elements required to be submitted by applicants to substantiate a NAS claim. Advanced Therapy Medicinal Products (ATMPs) are within the scope of this guidance. Consultation ends on 31 May 2023.

Newsletter: Clinical Trial Highlights – Issue 12, December 2022
Provides insights on clinical trials topics, including Accelerating Clinical Trials in the European Union (ACT EU) and Clinical Trials Information System (CTIS).

Newsletter: Human medicines highlights Issue 164, December 2022
Primarily addressed to organisations representing patients, consumers and healthcare professionals, this newsletter provides a summary of key information relating to medicines for human use published in December by EMA.

European Commission (EC)

European Commission proposes extension of Medical Device Regulation (MDR) transition periods in a bid to prevent medical device shortages

The EU MDR was adopted in 2017 and states that medical devices can be placed on the EU market under CE certifications issued in accordance with Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) until 26th May 2024. Following the transition period to the new rule, products require certification under the MDR. In a recent speech1 Commissioner Kyriakides2 proposed an amendment to the MDR to further extend the deadline for higher-risk devices to 2027 and for lower-risk devices to 2028. 

EU Guideline 2022/C 440/02, published 19 December 2022. Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

Contains supplementary advice (content and format) on the information sponsors must provide when applying for designation of a medicinal product as an orphan medicinal product.

European Directorate for the Quality of Medicines & HealthCare (EDQM)

EDQM releases new edition of the Tissue and Cells Guide

The updated 5th edition of the Guide to the quality and safety of tissues and cells for human application provides a comprehensive overview of the most recent advances in the field and practical support on all stages in the handling and treatment of tissues and cells, starting from identifying potential donors to clinical application in patients and their follow-up.

Health Research Authority (HRA)

Help shape the future of the HRA website

HRA is looking for volunteers to help test their new website after receiving feedback in 2022 that the current site isn’t user-friendly. Various periods of user testing are taking place from January until early May.

Volunteers to test new IRAS user guide

A new IRAS user guide has been developed to help find information more easily when using the system. It presents the same information as the current Step by step guide, but is presented in a different format and structure. The survey is open until 27 January 2023.


Health Canada published a revised List of recognised standards for medical devices. The document highlights the new standards added, standards updated and those removed.
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