GMP News - Pharmaceutical Development / Clinical Trials / GCP
GMP News - Pharmaceutical Development / Clinical Trials / GCP
08.11.22
EMA publishes ICH M11 (CeSHarP) for Comments
The EMA published the ICH M11 draft Guideline on the Clinical Electronic Structured Harmonized Protocol (CeSHarP) for comments. The comment period runs until February 26, 2023.
The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.
ICH Q5 A (R1) Revision: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.
How to Submit Documents with Real-World Data to FDA
To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.
The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.
The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to the agency. Read more about FDA´s regional ICH E2B (R3) Implementation Guideline.
Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?
The FDA issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.
The FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?
The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.
ANVISA´s Q&A on Medical Cannabis for Clinical Investigations
The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?
The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.
EMA Publishes Comments Received on ICH Q2(R2) and Q14
In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation. End of August, an overview of the comments received was provided.
USP Article: In Vitro Test Methods for Continuous Manufacturing
The continuous manufacture of medicinal products is a young, spreading type of modern pharmaceutical production. In contrast to classical batch manufacturing, these processes run continuously, i. e. dosing and product withdrawal run uninterrupted and are continuously monitored. A recent USP article discusses what release testing might look like.
In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.