Pharma GMP News of the Week: 19-March-2023
Period: March 12, 2023 to March 18, 2023
News from EMA “EMA finalises guidance on computerised systems and electronic data in clinical trials”
Date of news: March 9, 2023
The European Medicines Agency (EMA) has finalized a guideline on computerized systems and electronic data in clinical trials. This document is intended to help stakeholders adapt to increases in the complexity of computerized systems. It highlights the rapid changes that have occurred as electronic case report forms, electronic patient reported outcomes, wearable devices and artificial intelligence have become part of the clinical trial landscape. EMA has designed the guidance to help stakeholders use the new technologies while ensuring the quality and reliability of trial data and the rights, dignity, safety and wellbeing of trial participants.
FDA published draft guideline “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”
Date of news: March 13, 2023
The use of electronic systems, electronic records, and electronic signatures in clinical studies of foods, medicines, tobacco products, and new animal drugs under FDA regulations is covered in this draft guidance, which is information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties. When it is finalized, the guidance for industry titled Computerized Systems Used in Clinical Investigations will be replaced by the draft guidance for industry titled Use of Electronic Documents and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers (May 2007).
The guidance offers suggestions regarding the rules, including those outlined in 21 CFR part 11, according to which the FDA considers electronic systems, electronic records, and electronic signatures to be generally equivalent to paper records and handwritten signatures executed on paper and trustworthy, reliable, and so on.
Source: https://www.fda.gov/media/166215/download
News from EDQM “EDQM is conducting consultation on Council of Europe recommendation on remote and online medicine provision.”
Date of news: March 15, 2023
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is conducting a targeted consultation from 13 March to 26 May 2023 to seek the opinions of interested parties on a draft Council of Europe recommendation on best practices for the remote and online provision of medicines. The main goal of the recommendation is to provide guidance on minimum requirements to be fulfilled by stakeholders involved in the medication process to allow safe and equal access to medicines at a distance, but also to raise awareness of existing issues that may require action. This consultation is a valuable opportunity for stakeholders to express their views and inform the process, allowing the EDQM to finalise the draft recommendation in the most relevant manner possible.
FDA published guideline “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry”
Date of news: March 16, 2023
The Federal Food, Drug, and Cosmetic Act (FD&C Act) was changed by the Drug Supply Chain Security Act (DSCSA), Title II of Public Law 113-54, to set procedures for product tracking, verification, and identification for some drug goods marketed in the US. Section 581 of the FD&C Act provides definitions for many of the terminology used in these regulations (21 U.S.C. 360eee).
Source: https://www.fda.gov/media/111468/download
FDA published draft guideline “Pharmacogenomic Data Submissions”
Date of news: March 17, 2023
The Food and Drug Administration (FDA) has made a draft industry guidance document called “Pharmacogenomic Data Submissions” available. The goal of this draft guidance is to make pharmacogenomics research and the use of pharmacogenomic data in medication development easier. The goal of the proposed advice is to make it clearer how the FDA’s rules should be followed when submitting information for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs). This document also offers suggestions to applicants and sponsors regarding the structure and content of pharmacogenomic data submissions.
Source: https://www.fda.gov/media/166258/download
News from ICH “The ICH S12 Guideline reaches Step 4 of the ICH Process”
Date of news: March 17, 2023
Step 4 of the ICH Process for the ICH S12 Guideline on “Nonclinical Biodistribution Issues for Gene Therapy Products” was reached on March 14, 2023.
In accordance with the 3Rs (reduce/refine/replace) philosophy, this guideline aims to provide guidance on the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products that mediate their effect by the expression (transcription or translation) of transferred genetic materials, as well as unified recommendations to facilitate the development of GT products.
The S12 EWG has created a Step 4 Introductory Training Presentation to summarize the Guideline’s content.
Further details, such as the guideline and the Step 4 introductory training presentation, are available on the S12 page.
Source: ICH S12 Nonclinical Biodistribution Considerations for Gene Therapy Products