Regulatory Intelligence Digest - May 2022
Latest Regulatory Updates
May 2022
We are back this month with the latest guidance and updates from the regulatory agencies - FDA, EMA, EC, and MHRA.
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)
Draft Guidance: FDA releases new draft guidance on race and ethnicity plans to improve enrollment of underrepresented racial and ethnic populations in Clinical Trials?(new draft guidance)
In this guidance document, the FDA has provided recommendations to sponsors developing medical products in an approach to develop a Race and Ethnicity Diversity Plan. This will ensure adequate numbers of underrepresented racial and ethnic participants are enrolled in US Clinical Trials.?Read more.
Guidance: Minor updates to Refuse to Accept Policy for 510(k)s?(new final guidance)
FDA releases a new final guidance document for policy regarding procedures and criteria the FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a certain threshold of acceptability and should be accepted for substantive review. The minor updates and clarifications include: providing clarity that devices ineligible for 510(k) (for example, a device classified in class III requiring PMA) may be refused by the FDA and the correction of broken links.?Read more.
Guidance: FDA accepting comments on Draft PQ/CMC data exchange for electronic submission PQ/CMC date
To support future electronic acquisition and use of submitted information, the FDA has undertaken a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured submission approach. FDA has released the draft document, Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange, and is currently seeking feedback and comments on?how the PQ/CMC data elements are represented in HL7 FHIR.?Read more.
Comments are being accepted through May 17, 2022.
Guidance: FDA issues Final Guidance - Drug Products, Including Biological Products, that Contain Nanomaterials (new final guidance)
The FDA has announced the final guidance for industry "Drug Products, Including Biological Products, that Contain Nanomaterials." The?guidance provides industry with the agency's current guidance for the development of human drugs, including biologics, with nanomaterial present in the finished dosage form.?A glossary of terminology for clear definitions of critical terms used throughout the document is provided. Changes were made to section “505(j) Submissions” to align with the current review expectations of generic drugs containing nanomaterials. Read More.
Guidance:?FDA releases Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations?(new final guidance)
A final guidance on administering?bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements was issued by FDA.?The guidance recommends how to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration.?Read more.
Guidance: FDA releases guidance for Industry "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C"??(new final guidance)
FDA has released a final guidance, outlining the key elements of being recall ready.?The guidance outlines preparations that firms should consider making to establish recall initiation procedures to ensure faster and more accurate recall actions. FDA encourages companies to communicate quickly with supply chain consignees, such as distributors and the public about a voluntary recall. Read more.
Click here to listen to an Audio Podcast on Key Elements of Being "Recall Ready"?
Draft Guidance: FDA issued draft guidance: "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." (new draft guidance)
The new draft guidance replaces the draft guidance issued in 2018 and makes recommendations regarding the cybersecurity information to be submitted for devices, emphasising the importance of ensuring that devices are designed securely, ensuring cybersecurity risks are mitigated throughout the Total Product Life Cycle. It also outlines the FDA's recommendation for premarket submission content addressing cybersecurity concerns. Read more.
Regulation: A rule by the FDA regarding Medical Devices; Technical Amendments (new regulation)
New rule effective from March 29, 2022, updating the regulations with mailing address information and reducing the number of copies of certain documents that need to be submitted to the FDA. Read more.
European Medicines Agency (EMA)
News: EMA and the EUnetHTA 21 consortium publish joint work plan until 2023
The EMA and the?EUnetHTA 21 consortium have collaborated and published a joint work plan until 2023 to prepare for the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025. Read more.
Guidance: GMP and GCP Inspections?(New final guidance)
A new guidance document for applicants and Marketing Authorisation Holders has been published.?The document declares the minimum standards that medicines manufacturers must meet in production when involved in GMP and GCP inspections coordinated by EMA.?Read more.
领英推荐
"Regulatory and procedural guideline" (Update: version 2.8, 08 April 2022)
The IRIS guide for applicants on how to create and submit scientific applications has been updated. Read more.
Update: Guidance on Irish language derogation ending on 1 January 2022 (Revision 2, 07 April 2022)
Revision 2 clarifies?that all new marketing authorisation applications will require an INN translation in all EU languages including the Irish language. A questions and answers section has also been introduced at the end of the guidance. Read more.
Guidance: New draft guidance document was released on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)?(New draft guidance) Read more.
Updates to CTIS modular training programme
CTIS Update:?Presentation now made available for CTIS bitesize talk: Initial trial application (07 April 2022) Read more.
Revised ICH Guidance: E8(R1)) General considerations for clinical studies (Revised guidance) Read more.
Revised Guidance: Parallel EMA/EUnetHTA 21 joint scientific consultation.?(Revised guidance) Read more.?For more info see also.
Guidance: ICH harmonised guideline E11A on pediatric extrapolation Draft version endorsed 04 April 2022, open for public consultation (Draft guidance)
This guideline document provides recommendations for, and promotes international harmonization of, the use of pediatric extrapolation to support the development and authorization of pediatric medicines. The likelihood of substantial differences between regions should be reduced by the?harmonization of the approaches to pediatric extrapolation. Read more.
Guidance:?ICH guideline Q14 on analytical procedure development endorsed 24 March, open for public consultation (Draft guidance)
This guideline document provides science and risk-based approaches for developing and maintaining analytical procedures to ensure they are suitable for the assessment of the quality of drug substances and drug products. Read more.
Newsletter: Human Medicines Highlights?
The latest issue of the Human Medicines Highlights has been released. Read more.
Newsletter: CTIS Newsflash - 3 updates were published in April
CTIS Newsflash #09 Read more.
CTIS Newsflash #10?Read more.
CTIS Newsflash #11?Read more.
European Commission (EC)
New Guidance:?Questions and Answers Document – Regulation (EU) 536/2014 – Version 6 April 2022) (New final guidance) Read more.
News: Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) Read more.
Medicines and Healthcare products Regulatory Agency (MHRA)
Press Release - Open consultation:?MHRA seeking feedback to strengthen conflicts of interest policy for independent advisors
The open consultation can be accessed here. Consultation closes 24 May 2022. Read more.