GMP News - Regulatory Affairs

21.11.23

News on CEP 2.0: Specifications

The EDQM has once again published further information on its website with regard to the "CEP 2.0". The presentation and content of section 3.2.S.4.1 Specification are now discussed and explained.

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02.11.23

EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.

In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.

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02.11.23

Warning Letter to Swiss Manufacturer of Homeopathic Eye Drops

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.

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26.10.23

Revised USP Chapter <660> Glass Containers

Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".

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26.10.23

Quality Attributes for Ophthalmic Drug Products

The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

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26.10.23

EMA Publishes revised CTIS Transparency Rules

The EMA has endorsed the revised transparency rules for the EU Clinical Trials Information System (CTIS). According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.

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26.10.23

Key Factors for Compassionate Use

The FDA published a draft guidance for institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions (IPEAS).

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26.10.23

FDA's final Guidance on Real-World Data and Real World Evidence

The U.S. Food and Drug Administration (FDA) issued the final guidance for the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to support regulatory decision-making for drugs and biological products. What are the sponsor's responsibilities?

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25.10.23

FDA Publishes Structured Product Labeling Guide for Cosmetic Products

The U.S. Food and Drug Administration has published an updated structured product labeling (SPL) implementation guide with validation procedures for cosmetic product facility registrations and product listings.

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05.10.23

EMA: Updates in the Product Lifecycle Management (PLM) Portal

New and revised guidance documents and materials related to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).

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05.10.23

BfArM/PEI: Guideline "Designation of Medicinal Products" published

The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.

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05.10.23

EDQM: CEP 2.0 implemented

Since beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only.

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05.10.23

EMA's Questions and Answers on the Biological Medicines Marketing Authorisation Dossier Published

Biological medicinal products are gaining more and more interest. Due to the ever increasing complexity and diversity within these medicinal products, more questions arise. The EMA has now published a Q&A document to support the marketing authorisation holders presenting the information in the dossier correctly.

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04.10.23

FDA issues new Guidance on Remote Oversight Tools

The FDA has published a new guidance document on the possible use of alternative methods in the preparation of inspections or in place of inspections for marketing authorisation applications that are still pending.

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04.10.23

USP: Excipient Stimuli published for Comments

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

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