Pharma GMP News of the Week: 6-November-2022

Period: October 30, 2022 to November 5, 2022

The Medical Device Coordination Group (MDCG) has issued guidelines on authorised representatives’ roles and responsibilities under the new medtech rules.

Date of news: October 31, 2022

MDCG unpacks the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) for authorised representatives, manufacturers, and other economic operators in the guidelines.

Manufacturers without a presence in a member state are required by EU legislation to select a solitary authorised representative who serves as their EU contact person and is critical to maintaining compliance. MDR and IVDR define authorised representatives’ obligations and expand their responsibilities.

Source: https://health.ec.europa.eu/document/download/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en?filename=mdcg_202216_en.pdf 

FDA published draft guideline on “Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability”

Date of news: October 31, 2022

This guidance is designed to help sponsors track growth and, where necessary, pubertal development in paediatric study participants with both uncommon and common disorders. This guideline offers suggestions for the best ways to gauge pubertal development and measure and record growth in order to assess safety.

Source: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials

FDA published final guideline on “Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide”

Date of news: November 1, 2022

This guideline was created by the FDA in compliance with Section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). It aims to aid small entity businesses that produce human cells, tissues, or cellular or tissue-based products (HCT/Ps) in understanding the thorough regulatory framework for HCT/Ps that is outlined in Title 21 of the Code of Federal Regulations, part 1271. (21 CFR 1271). Important terminology used in 21 CFR 1271 are defined in section 21 CFR 1271.3.

Source: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide Guidance for Industry

FDA published draft guideline on “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers”

Date of news: November 1, 2022

In order to comply with FDA regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which took effect on October 13, 2009, this guidance provides information for business, researchers, physicians, institutional review boards (IRBs), and patients. Regarding the execution of the legal requirements for wider access, FDA got a lot of inquiries.

Source: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers 

FDA published draft guideline on “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program”

Date of news: November 1, 2022

In accordance with sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which were added by the Coronavirus Aid, Relief, and Economic Security Act (or the CARES Act), the Food and Drug Administration (FDA) is authorised to charge and collect user fees from qualified manufacturers of OTC monograph drugs and requestors of OTC monograph order requests, other than OMORs fo The several OMUFA fee kinds, payment deadlines, and fee exclusions are all included in this guideline. Additionally, this advice outlines the FDA fee submission procedure, the penalties for not paying the requisite fees, and the refund submission procedure.

Source: https://www.fda.gov/media/162759/download 

FDA published final guideline on “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals”

Date of news: November 2, 2022

All medications that must undergo carcinogenicity testing in accordance with ICH S1A are covered by this Addendum. Refer to the ICH industry guidance S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012) for information on pharmaceuticals derived from biotechnology.

Source: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals | FDA 

FDA published final guideline on “Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry”

Date of news: November 2, 2022

Oncology medication approvals frequently enhance the therapeutic effectiveness of existing regimens by include new pharmaceuticals or by merging experimental medicinal products to form a combination regimen, resulting in new regimens with higher efficacy. Historically, applicants have not asked for modifications to a drug’s labelling to explain how to take it in a different regimen (cross labeling). Cross labelling for cancer medication combination regimens has, however, been recommended in an increasing number of recent applications. This advice outlines the FDA’s current recommendations for adding pertinent information in the labelling for cancer treatments approved for use in a combination regimen, as well as significant factors for the cross-labeling of these medications.

Source: Cross Labeling Oncology Drugs in Combination Regimens 

News from EMA: By the end of November, EMA invites businesses to submit type I variations for 2022.

Date of news: November 3, 2022

Marketing authorization holders are encouraged by the European Medicines Agency (EMA) to submit type IA and type IAIN variations for 2022 by no later than Wednesday, November 30, 2022. This will allow EMA to validate the submissions within the 30-day window specified in Article 14 of Commission Regulation (EC) No 1234/2008 and prior to the Agency’s closure between December 23, 2022, and January 3, 2023.

Source: Regulatory update – EMA encourages companies to submit type I variations for 2022 by end of November | European Medicines Agency 

FDA published final guideline on “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

Date of news: November 4, 2022

This guideline is intended to offer suggestions to sponsors looking to test several iterations of a cellular or gene therapy product in an early-phase clinical trial for a particular condition. In a single clinical study, sponsors have indicated interest in obtaining preliminary proof of the efficacy and safety of several iterations of a cellular or gene therapy product. Although several product versions can be tested simultaneously in a clinical study, each product version is unique and is typically submitted to the FDA in a separate investigational new drug application (IND). These early-phase clinical trials are intended to provide guidance on which product version or versions to pursue for additional development in later-phase investigations.

Source: Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Guidance for Industry 

FDA published final guideline on “M10 Bioanalytical Method Validation and Study Sample Analysis”

Date of news: November 4, 2022

The guidelines include the procedures and processes that should be characterised for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects. They also include recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions. The purpose of the advice is to give the industry unified regulatory standards for the validation of bioanalytical methods employed in assays used to support regulatory submissions. The guideline takes the place of the June 27, 2019, draught draft advice titled “M10 Bioanalytical Method Validation.

Source: https://www.fda.gov/media/162903/download

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