#RegulatoryAffairsUpdate List- September 19th

USA

FDA Industry Guidance on Regulatory Considerations for Software Related to Prescription Drug Use - September 2023

This guidance document outlines the FDA's approach to the application of its regulatory authority concerning specific software outputs. These outputs are distributed by or on behalf of a drug sponsor and are intended for use with prescription drugs or combination products consisting of a prescription drug and a medical device (referred to as "combination products"). These combination products are under the oversight of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) as the lead regulatory center. This guidance document further elaborates on and has been formulated in response to comments received following the Federal Register notice titled "Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.??

https://www.fda.gov/media/172165/download

Labeling Guidelines for Biosimilar and Interchangeable Biosimilar Products" - Released in September 2023.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-biosimilar-and-interchangeable-biosimilar-products

"Additional Draft Questions and Answers on Biosimilar Development and the BPCI Act (Revision 1) - Draft Guidance for Industry" - Released in September 2023.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilarity-and-interchangeability-additional-draft-qas-biosimilar-development-and-bpci-act

Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.? This guidance document explains, among other things:

• The statutory requirement to submit cosmetic product facility registrations and product listings;
• Definitions;
• Who is responsible for making the submissions;
• What information to include in the submissions;
• How to make the submissions; and
• When to make the submissions.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products

CANADA

Draft guidance for determining medical device application type: September 2023

This guide offers manufacturers assistance regarding various application types specified within the Medical Devices Regulations (regulations). These application types encompass:

• Medical device family
• Medical device group
• Medical device group family
• System
• Test kit

Additionally, this document furnishes manufacturers with guidance on the process of ascertaining whether specific medical devices, including their components and parts, can be consolidated and submitted as a single device license or authorization application. This procedure is outlined in:

• Sections 28 to 31 within Part 1 of the regulations
• Sections 68.04 to 68.09 within Part 1.1 of the regulations

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-determining-medical-device-application-type.html

EUROPE

EMA/CHMP/185423/2010, Rev.3: Preliminary Guide on Clinical Investigation of Medicinal Products for Depression Treatment, September 2023

This document serves as general advice regarding the development of pharmaceutical products for addressing Major Depressive Disorder (MDD), both in its acute and long-term manifestations. The primary focus is on major depressive episodes occurring within the context of MDD. Bipolar and related disorders are distinct from depressive disorders in DSM-5, and any potential extensions, in accordance with the bipolar guidance document, will also be considered.

This updated guideline specifically addresses the following:

• Various aspects of trial design for challenging-to-treat patients, such as partial responders or non-responders to treatment. This includes defining and identifying such patients, as well as exploring the role of augmentation and combination strategies.
• Clinical development requirements for novel fast-acting therapies.
• Considerations for the development of psychedelic medications and the emerging paradigm of psychedelic-assisted psychotherapy in the realm of MDD.
• Clinical development prerequisites for targeting specific sub-domains of depression.
• Criteria for conducting clinical trials in children and adolescents, with the possibility of extrapolation from adult data.
• Examination of gender and drug metabolism differences within patient populations.

Upon finalization, this guideline will supersede EMA/CHMP/185423/2010 Rev. 2.

This document replaces EMA/CHMP/183826/2016: Concept Paper on the Necessity for Revising the Guideline on Clinical Investigation of Medicinal Products for Depression Treatment, dated November 10, 2016.

The EMA has released this document for the purpose of collecting comments. Feedback should be submitted using the EUSurvey form at https://ec.europa.eu/eusurvey/runner/dc619ed9-ffc1-e4b9-4592-835bcde50738.

Please note that the guideline has been republished, and the deadline for comments is March 31, 2024.

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-depression-revision-3_en.pdf

SWITZERLAND

Regulation of medical devices : Basic information on medical devices 13/09/2023

In contrast to medicinal products, medical devices do not undergo an official authorization procedure. Instead, Switzerland adheres to the compliance assessment and certification system established by the European Union (EU) through bilateral agreements. The evaluation of adherence to internationally recognized standards is conducted by private entities.

Medical devices are categorized based on their level of risk, each requiring specific assessment procedures. The visible outcome of a compliance assessment is the issuance of the CE label. This label allows medical devices to be introduced to the market in the EU and, due to the unilateral recognition of the CE label, in Switzerland as well.

Swissmedic's primary focus in the realm of medical devices centers on rigorous market surveillance. Additionally, the responsibility for designating and overseeing conformity assessment bodies and the development of technical standards requirements also falls under the purview of Swissmedic.

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices.html

Introduction of the SwissGMDP Database September 10, 2023

Swissmedic is in the process of implementing the SwissGMDP database, akin to the European Medicine Agency's (EMA) EudraGMDP database. This database will encompass a comprehensive listing of GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certificates held by all companies in Switzerland that possess a valid establishment license issued by Swissmedic. Notably, the certificates featured in the SwissGMDP database will encompass all authorized activities. Unlike EudraGMDP, this will encompass both GDP activities and Switzerland-specific GMP activities of Swiss companies. This user-friendly database will be accessible to all companies, regulatory authorities, and individuals, allowing them to conveniently verify a company's GMP/GDP status.

The launch of the SwissGMDP database is anticipated to take place on the Swissmedic website (www.swissmedic.ch) in the first quarter of 2024, with the exact date set to be announced in the upcoming months.

Link to the announcement

UK

Guidelines Released on Novel International Regulatory Recognition Pathways for Medicines Approvals

The Medicines and Healthcare products Regulatory Agency (MHRA) has released extensive guidance pertaining to the recently introduced International Recognition Procedure (IRP) designed for medicine manufacturers. This guidance encompasses detailed instructions on how to initiate the application process for obtaining a medicine license

https://www.gov.uk/government/news/guidance-published-on-the-new-international-regulatory-recognition-routes-for-medicines-approvals

MALAYSIA

Determination Regarding the Adoption and Prerequisites for Quality Management System (QMS) and Traceability Form. August 2023

https://www.mda.gov.my/doclink/decision-from-mesyuarat-jawatankuasa-teknikal-pendaftaran-umum-requirements-on-qms-and-traceability-form-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJkZWNpc2lvbi1mcm9tLW1lc3l1YXJhdC1qYXdhdGFua3Vhc2EtdGVrbmlrYWwtcGVuZGFmdGFyYW4tdW11bS1yZXF1aXJlbWVudHMtb24tcW1zLWFuZC10cmFjZWFiaWxpdHktZm9ybS0yLXBkZiIsImlhdCI6MTY5MTM3MDQzMCwiZXhwIjoxNjkxNDU2ODMwfQ.VehVL8Ch2CX_SKP24NAlpy--EIFvF6q68qWtgki89zA

CHINA

CDE Notification: Invitation for Public Input on Draft Technical Guidelines for Gene Therapy Product Clinical Trials in Rare Diseases, September 12, 2023

In recent years, the Center for Drug Evaluation (CDE) has received numerous communications and applications for clinical trials involving gene therapy products aimed at treating rare diseases. To provide guidance and establish standardized protocols for the design of clinical trials involving gene therapy products for rare diseases, they have developed the "Technical Guidelines for Clinical Trials of Gene Therapy Products for Rare Diseases" and are now seeking input from the public.

These guidelines amalgamate the unique characteristics of rare diseases with gene therapy products, offering recommendations for the research and development of such therapies for rare diseases. They also serve as a valuable reference for conducting clinical trials involving gene therapy products for rare diseases. The primary contents of these guidelines are categorized into four sections, which include an overview, general considerations, key aspects of clinical trial design, and strategies for risk management.

Invitation for Public Input on Draft Technical Guidelines for Mesenchymal Stem Cell Clinical Trials in Graft-Versus-Host Disease Prevention and Treatment, September 12, 2023

Clinical trials involving mesenchymal stem cells for the prevention and treatment of graft-versus-host disease are rapidly advancing both domestically and internationally. To enhance the efficiency of research and application of related products and to swiftly address the clinical needs of patients, the "Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for the Prevention and Treatment of Graft-Versus-Host Disease." has been developed and public input on this draft is required.

These guidelines are applicable to mesenchymal stem cell products derived from various sources, including bone marrow, umbilical cord, umbilical cord blood, adipose tissue, as well as mesenchymal-like cell products derived from the differentiation of embryonic stem cells or induced pluripotent stem cells.

The guideline is structured into three main sections: an overview, considerations for clinical trials, and guidelines for engaging with regulatory agencies. It primarily outlines the factors that should be taken into account during clinical trials. Sponsors are encouraged to engage in timely communication with regulatory agencies for more specific details. These guidelines are intended for drug research and development purposes aimed at registration; however, they can also be referenced for other clinical studies.

HONGKONG

Guidelines for Requesting Changes to Wholesale Dealer License/ Antibiotics Permit/ Wholesale Dealer's License for the Distribution of Hazardous Drugs, September 2023

The objective of this document is to offer instructions for the submission of requests to modify the details of Wholesale Dealer License/ Antibiotics Permit/ Wholesale Dealer's License for the Distribution of Hazardous Drugs.

This document is structured into the following sections:

• Prerequisites for Application
• Procedures for Application
• Outcomes of Application
• Stipulated Fees and Accepted Payment Methods

Additionally, it includes an Application Form and a Checklist encompassing specific details and required documents.??

VENEZUELA

Draft Regulation on Medicinal Product Naming, September 2023

The primary aim of this regulation is to establish clear criteria and conditions governing the approval of names for medicinal products that are subject to marketing authorization. By doing so, it seeks to enhance their identification, facilitate marketing, and ensure safe usage by minimizing the risk of errors.

As indicated in Circular RC 003, this document will be accessible from September 7th, 2023, to September 29th, 2023.

Feedback and comments can be provided through the following link: Link to Feedback Form.

EGYPT

Draft Guidelines for Regulating Post-Approval Changes to Registered Biological Products in Egypt, September 10, 2023

The Egyptian Drug Authority (EDA) has released a draft guideline aimed at providing Manufacturers Authorization Holders (MAH) with comprehensive guidance on the regulation and assessment of Post-Approval Changes (PAC) for registered biological products. These changes are categorized into quality modifications, labeling adjustments, and administrative alterations. The guideline outlines the general procedure, necessary documentation, timelines, and reliance mechanisms for PAC evaluation.

To establish a robust framework for regulating PAC for both imported and locally manufactured products, the EDA has drawn upon various international guidelines, including the World Health Organization (WHO) "Annex 3 guidelines on procedures and data requirements for changes to approved biotherapeutic products," "Annex 4: guidelines on procedures and data requirements for changes to approved vaccines," and "guidance on variation to a prequalified vaccine." Additionally, the guideline incorporates insights from the European Medicines Agency (EMA) through its "Guidelines on the details of the various categories of variations (2013/C 223/01)."

Stakeholders can provide comments and feedback on this draft guideline through the attached public consultation form. Comments can be submitted to [email protected].

https://www.edaegypt.gov.eg/media/tjvb3rao/draft-changes-guideline-for-public-co.pdf