GMP News - Regulatory Affairs

28.09.22

EMA: New Update of the "IRIS" Documents

In September 2022, the documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were updated again - now containing some innovations and revisions.

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21.09.22

EMA/CHMP: New Active Substance Guideline? Concept Paper published for Comments

Since the end of July, the "Concept paper on the revision of the guideline on the chemistry of active substances" of the CHMP's (Committee for Medicinal Products for Human Use) Quality Working Party (QWP) is available for public comments. This document aims to clarify the need to revise and update the guideline "Guideline on the chemistry of active substances (EMA/454576/2016)".

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20.09.22

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.

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20.09.22

Charging for IMPs? FDA has some Answers

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 The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain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.  

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20.09.22

FDA publishes Answers to GCP Questions

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")?

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13.09.22

FDA's recommended Font and Font Size for Instructions for Use Labeling

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

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07.09.22

Ph. Eur. Survey for DEHP Plasticiser Alternatives

Due to a change in REACH, the Ph. Eur. is considering to replace the plasticiser DEHP and is therefore seeking information from manufacturers. The deadline for replies is 30 September 2022.

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31.08.22

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.

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24.08.22

China GMP: New Annex 13 for IMPs

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.

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18.08.22

China GMP and Registration of APIs - Q&As

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers team.

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18.08.22

Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations

EMA's Question and Answer document on nitrosamine impurities is addressed to marketing authorisation holders. This document describes the approach to review the manufacturing processes for chemically-synthesised and biological medicinal products and to do the risk assessments accordingly. Read more about which new deadlines for variations have to be observed and what has changed in the forms.

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18.08.22

CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).

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10.08.22

HMPC´s Update on Medical Cannabis

The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?

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03.08.22

FDA expands Remote Regulatory Assessments

The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

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03.08.22

New Questions and Answers from the EMA regarding Titanium Dioxide in Medicines

Despite being forbidden as food additive titanium dioxide may still be used provisionally in medicinal products. But the EMA appeals to the pharmaceutical companies to seek intensively for alternative excipients and has published a new questions and answers document to provide assistance. Read here what marketing authorisation holders and applicants have to observe when replacing titanium dioxide or developing new formulations for medicinal products with alternative excipients.

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