#RegulatoryAffairsUpdate List- July 11th
Valerie VIEILLEDENT, MBA 📂Regulatory Affairs Leader
My #RegulatoryAffairsUpdate List provides the selection of interesting regulations updates of the last couple of weeks
USA
Guidance for the Clinical Investigation of Psychedelic Drugs: Considerations for Industry Stakeholders, Jun-2023
The U.S. Food and Drug Administration (FDA or Agency) has released this guidance to offer general considerations for sponsors involved in the development of psychedelic drugs for medical conditions, including psychiatric disorders and substance use disorders. In this guidance, the term "psychedelic" encompasses classic psychedelics such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens like methylenedioxymethamphetamine (MDMA). The scope of this guidance extends to clinical trials conducted under an investigational new drug application (IND), including research or academic studies that do not intend to support marketing applications. The principles outlined in this guidance aim to promote the ethical conduct of clinical trials, ensure trial integrity, and maintain the reliability of the obtained results.
Guidance for the Manufacture of Cold-Stored Platelets for Active Bleeding: Alternative Procedures and Exceptions, Jun-2023
The Food and Drug Administration (FDA) has released this guidance to announce exceptions and alternatives to specific requirements in Title 21 of the Code of Federal Regulations (CFR) concerning blood and blood components. This notice, issued under 21 CFR 640.120(b), aims to address the urgent and immediate need for platelets in the treatment of active bleeding when conventional platelets are unavailable or impractical to use. The guidance acknowledges the importance of ensuring platelet availability in challenging circumstances such as military, prehospital, or austere settings, as well as during mass casualty events or public health emergencies, to ensure timely access to platelets for patients experiencing active bleeding.
Furthermore, the guidance offers recommendations to blood establishments regarding the manufacturing and labeling of cold-stored platelets (CSP). It also highlights the need for additional data on the efficacy of CSP, specifically addressing situations where conventional platelets are available and practical to use.
Recommendations for Communicating Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements, Jun-2023
This guidance offers guidance on the presentation of quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drug and biological products, prescription animal drugs, and over-the-counter animal drugs (collectively referred to as promotional communications). Quantitative efficacy and risk information, as defined in this guidance, includes numerical information related to the effectiveness or potential risks of a drug.
The finalized guidance builds upon the draft guidance titled "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements," which was initially issued on October 17, 2018.
The changes made from the draft to the final guidance include:
FDA Releases Initial Draft Guidance on Clinical Trials with Psychedelic Drugs, 23-Jun-2023
In a recent press release, the FDA announced the publication of a new draft guidance aimed at providing essential considerations to researchers exploring the potential use of psychedelic drugs in the treatment of various medical conditions, including psychiatric disorders and substance use disorders. This draft guidance marks the FDA's first attempt to offer industry-specific recommendations for designing clinical trials involving psychedelic drugs. Its primary objective is to offer guidance to researchers regarding study design and other pertinent factors as they develop medications containing psychedelic substances. Within this draft guidance, the term "psychedelics" encompasses "classic psychedelics" such as psilocybin and lysergic acid diethylamide (LSD), which act on the brain's serotonin system, as well as "entactogens" or "empathogens" like methylenedioxymethamphetamine (MDMA). The document covers fundamental considerations throughout the drug development process, including trial conduct, data collection, subject safety, and requirements for new drug applications.
CANADA
Guideline: Procedures and Administrative Requirements for Master Files (MFs), 01-Jun-2023
The purpose of this guideline is to provide comprehensive information on Master Files (MFs), including definitions, filing requirements, processing and assessment procedures for various types of MFs (Type I to V). Additionally, it outlines the registration requirements for new MFs and covers other MF transactions such as administrative changes, updates, withdrawals, and closures.
This guideline is applicable to all MF Holders or Applicants who utilize an MF to support drug submissions and DIN (Drug Identification Number) applications for human use or CTAs (Clinical Trial Applications). It is also intended for Health Canada employees involved in the MF processes.
The revision of this document was necessitated by the need to accommodate changes for the implementation of an XML web-based application process.
This updated guideline supersedes the previous version titled "Guideline: Master Files (MFs) - Procedures and Administrative Requirements, 01-Dec-2021. »
EUROPE
EMA/250551/2023: Interim Guidance on Parallel Scientific Advice between EMA and HTAb Bodies, 03-Jul-2023
This document offers guidance on the interactions between medicines developers, regulators, and Health Technology Assessment bodies (HTAbs) or other relevant stakeholders. Its purpose is to facilitate discussions on the development plan of a medicinal product at an early stage.
The guidance covers the following areas:
EMA/698382/2021: Guideline on Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol, 30-Jun-2023
The purpose of this document is to provide practical guidance on the notification process for serious breaches of the Clinical Trials Regulation. It offers advice on the classification of serious breaches, what must be reported, and outlines the possible actions that EU/EEA Member States may take in response to such notifications.
Please note that this guideline does not cover notifications related to unexpected events, other reporting obligations regarding the safety of trial participants, or urgent safety measures as defined in Articles 53 and 54 of Regulation (EU) No 536/2014.
This revised version of the guideline includes the addition of the HMA logo in the header and minor typographical corrections. The overall content remains unchanged from the previous version, EMA/698382/2021: Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol, issued on 13-Dec-2021.
EMA/CHMP/ICH/295401/2023: Draft Reflection Paper by ICH on Proposed Harmonisation of Real-World Evidence Terminology and Convergence of Principles for Planning and Reporting Studies using Real-World Data, with a Focus on Medicinal Effectiveness, 30-Jun-2023
The purpose of this draft reflection paper is to promote the harmonisation of terminology related to real-world evidence (RWE) and facilitate the convergence of general principles for planning and reporting studies that utilize real-world data (RWD). The aim is to enhance the use of RWE in regulatory decision-making processes.
This document represents an initial step towards the gradual harmonisation of regulatory guidance on RWE.
The European Medicines Agency (EMA) has released this draft document for the purpose of gathering comments. The deadline for submitting comments is 30-Sep-2023.
EMA/599977/2012 Rev. 2: Guidance on Publishing Information about Withdrawals of Marketing Authorisation Applications and Variations/Extensions to Marketing Authorisations, 27-Jun-2023
This guidance document provides detailed information regarding the publication of withdrawals of marketing authorisation applications for human medicinal products, as well as withdrawals of applications for variations/extensions to marketing authorisations.
The current revision of this document incorporates substantial modifications compared to the previous version, EMA/599977/2012 rev. 1: Procedural Advice on Publication of Information on Withdrawals of Applications Related to the Marketing Authorisation of Human Medicinal Products, dated 25-Jun-2013.
EMA Press Release: Review of Real-World Evidence Studies in Regulatory Decision Making, 23-Jun-2023
In this press release, the European Medicines Agency (EMA) announces the publication of a review highlighting the value of real-world evidence (RWE) in regulatory decision making. The report focuses on the experience gained by EMA in conducting studies using real-world data (RWD) over the past year and a half. This initiative is part of EMA's ongoing efforts, in collaboration with the European Medicines Regulatory Network (EMRN), to facilitate the integration of RWD into regulatory processes. RWE, which utilizes data obtained from routine healthcare sources, has become increasingly important in pharmacovigilance.
EMA and EMRN are actively working to establish a sustainable framework that promotes the use of RWE throughout the entire product lifecycle. The report covers the period from September 2021 to the first anniversary of the Data Analysis and Real-World Interrogation Network DARWIN EU on 7 February 2023. It outlines the identification of 61 research opportunities related to RWD, with 30 studies initiated and 27 completed during this timeframe.
The report offers recommendations to address the identified opportunities and challenges associated with RWE utilization. These recommendations include expanding access to additional data sources, implementing strategies to expedite RWE generation, proactively identifying research needs to enhance RWE capacity, and fostering close collaboration between decision-makers and stakeholders.
CHINA
CDE Notification: Requesting Public Comment on Pertinent Opinions to Expedite the Communication and Application of Compound Preparations of Traditional Chinese Medicine with Ancient Classic Prescriptions (Draft), 05-Jul-2023
To advance the inheritance, innovation, and high-quality development of traditional Chinese medicine, as well as accelerate the research, development, and application of compound preparations of traditional Chinese medicine (referred to as Class 3.1 traditional Chinese medicine) managed according to the catalog of ancient classic famous prescriptions, the draft document titled "Pertinent Opinions to Expedite the Communication and Application of Compound Preparations of Traditional Chinese Medicine with Ancient Classic Prescriptions" is being circulated for public comments.
The Center for Drug Evaluation (CDE) has put forward the following opinions:
Additionally, the draft includes dossier requirements for the communication and exchange of pharmaceutical information on compound preparations of traditional Chinese medicine managed according to the catalog of ancient classic famous prescriptions. These requirements encompass aspects such as variety profile, medicinal material research, and benchmark studies.
The document also provides a drafting explanation and feedback form for stakeholders' convenience.
CDE Notification No. 2023/38: Guidelines for the Acceptance and Review of Chemical APIs Registration (Trial), 30-Jun-2023
In compliance with the requirements stated in NMPA Announcement No. 2020/46: Issues related to the Implementation of Drug Registration Regulation, 30-Mar-2020, the Center for Drug Evaluation (CDE) has developed the Guidelines for the Acceptance and Review of Chemical APIs Registration (Trial) under the guidance of the National Medical Products Administration. The objective is to facilitate the development of supporting normative documents and technical guidelines.
These guidelines are applicable to the registration of marketing applications for chemical active pharmaceutical ingredients (APIs). They have been formulated based on the existing laws and regulations. For matters not covered or specified in this guide, registrants can consult with the acceptance department. Updates will be made in a timely manner in accordance with relevant laws, regulations, and other documents.
The document includes the following:
This document supersedes the CDE Notification: Re-soliciting Public Comment on Guidelines for the Acceptance and Review of Chemical APIs Registration (Trial) (Draft), issued on 09-Feb-2022.
CDE Notification: Seeking Public Input on Draft Technical Guidelines for Non-clinical Research of Therapeutic Radiopharmaceuticals, 26-Jun-2023
The field of radiotherapy drugs in China has witnessed significant growth due to the widespread use of new medical nuclides and the rapid advancement of targeting ligands. However, there is currently a lack of specific technical guidelines for conducting non-clinical research on these drugs in China. In order to promote and standardize the research and development of radiotherapy drugs, the Technical Guidelines for Non-clinical Research of Therapeutic Radiopharmaceuticals has been drafted and is now open for public comments.
These guidelines focus on the non-clinical research of therapeutic radiopharmaceuticals administered systemically. They aim to address the unique considerations associated with these types of drugs during the preclinical stage.
The document encompasses the following key aspects:
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The aim of seeking public input on this draft is to gather valuable insights and feedback from stakeholders to ensure the guidelines effectively address the non-clinical research requirements for therapeutic radiopharmaceuticals in China.
INDONESIA
Regulation of the Minister of Health of the Republic of Indonesia No. 04 Year 2023: Implementation Guidelines for Plasma Fractionation, 17-Jan-2023
This regulation provides detailed guidelines concerning the quality, safety, and efficacy of plasma-derived drug products to ensure public protection. Plasma fractionation involves the separation of plasma derivatives into plasma products through the utilization of blood processing technology. Plasma products refer to finished preparations obtained through plasma fractionation that possess medicinal properties. The primary objective of this document is to serve as a reference for plasma fractionation facilities, blood transfusion units, and other relevant stakeholders involved in the plasma fractionation process.
The contents of the regulation are as follows:
Chapter I: General Requirements
Chapter II: Plasma Fractionation Facilities
Chapter III: Performance of Plasma Fractionation
Chapter IV: Price of Plasma Derivative Drug Products
Chapter V: Recording and Reporting
Chapter VI: Guidance and Supervision
JAPAN
PMDA/OMIE Guideline: Key Considerations for Developing a Research Implementation Plan to Validate Outcome Definitions, 10-May-2023
This guideline aims to facilitate the validation of outcome definitions and enhance the overall quality of pharmacoepidemiological surveillance and post-marketing database surveillance conducted by PMDA. It provides a comprehensive summary of the essential elements that should be included as a reference in research plans.
The document offers guidelines and instructions for preparing the following components:
By following these guidelines and including the specified information in the research implementation plan, stakeholders can contribute to the validation of outcome definitions and enhance the quality of research conducted by PMDA.
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PAKISTAN
Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs, June 15, 2023
Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:
SOUTH KOREA
MFDS Notification No. 2023-192: Implementation of Regulations for Classification and Support of Next-Generation Biopharmaceuticals, 30-Jun-2023
The Ministry of Food and Drug Safety (MFDS) has introduced regulations governing the classification and support for the commercialization of next-generation biopharmaceuticals.
Considering the increasing development and expansion of next-generation biopharmaceuticals beyond the classification and concept of existing drugs, these regulations have been enacted to establish a proactive regulatory support system. The objective is to provide comprehensive support for the classification and commercialization of next-generation biopharmaceuticals, covering aspects ranging from early discovery to product classification, and the establishment of approval/review standards and facility standards.
The main contents of this notification include:
This document supersedes the previous draft version, No. 2023-198: Establishment of Regulation on Classification and Support for Commercialization of Next-Generation Biopharmaceuticals (Draft), issued on 18-Apr-2023.
BRAZIL
ANVISA New Medical Device Regulation RDC 751/2022
Discover the impact of ANVISA's new RDC 751/2022 regulation on medical devices in Brazil and its impact on medical devices in Brazil:
Scope and Purpose:
Applicability:
Significant Modifications:
Recommendations for Manufacturers:
In summary, RDC 751/2022 brings substantial changes to the regulation of medical devices in Brazil, addressing technological advancements and aligning with international standards.
EGYPT
Guidelines on the Rules and Procedures for Listing Active Pharmaceutical Ingredients (APIs) in Medicinal Products (Version 1.0), 05-Jul-2023-
This guideline focuses on regulating the rules and procedures for the voluntary listing of active pharmaceutical ingredients (APIs) in submitted medicinal products. Its primary objective is to establish a public database that includes quality files of approved APIs by the Egyptian Drug Authority. The quality file of an API, also known as Drug Master File/Quality Module 3 "S-Part," contains essential information such as the chemical description of the API, its manufacturing site and method, specifications, limits of impurities, analytical methods, validation procedures, storage data, and validity period of use.
These guidelines apply to API manufacturers located within or outside the Arab Republic of Egypt, their agents or legal representatives, as well as licensed medicinal product manufacturers or companies recorded in the toll manufacturing register. The procedures outlined in the guidelines cover the following:
By implementing these guidelines, the aim is to ensure transparency and maintain a comprehensive record of approved APIs for medicinal products in Egypt.
EDA Guideline: Registration Process for Innovative Products, 20-Jun-2023
In accordance with EDA Chairman Decision No. 388 of 2023, these guidelines have been developed to provide companies of innovative products with a comprehensive framework for registering their products in Egypt. The guidelines cover various aspects of the registration process, including:
Annexes to the guidelines include a request inquiry form and a template for the scientific evaluation of innovative products.
NIGERIA
NAFDAC Guideline: Preparation of Summary of Product Characteristics (SmPC) for Drug Products, Jun-2023
This guideline outlines the requirements for preparing the Summary of Product Characteristics (SmPC) for medicinal products in Nigeria.
The SmPC should be regularly updated to reflect new data and changes, which must receive regulatory agency approval before implementation.
This guideline offers guidance on the principles and content of the SmPC, including advice on presenting information effectively.
Additionally, the guideline includes the following Annexes:
These Annexes are also available as separate documents on the NAFDAC website, provided in a user-friendly format for easy reference.