GMP News - Regulatory Affairs

18.02.20

Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.

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17.02.20

New GMP Guidance for Marketing Authorisation Holders

After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.

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17.02.20

France Takes Further Steps Regarding Medical Cannabis

The French National Agency for Medicines and Health Products Safety carries on the work on medical cannabis started in 2018 and has now published a dossier on cannabis for medical use.

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05.02.20

Brexit: Consequences for Batch Release

During the transition period, all EU laws remain applicable in the UK. Does that mean that QP certification by UK QPs will still be valid across the EU? Not really, as a statement by the EQPA explains.

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29.01.20

Update on Ph. Eur. and Pharmeuropa

The EDQM recently announced some upcoming changes to the European Pharmacopoeia and Pharmeuropa.

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29.01.20

Medicinal Products for Human Use: EMA's Highlights 2019

The EMA has published the highlights for human medicines for 2019. These include 30 new APIs and one cannabis product.

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22.01.20

Changes to Pharmacopeial Forum

The United States Pharmacopeia is currently introducing some changes to the format of the USP and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review.

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16.01.20

From GVP to GMP: MHRA´s tips for QPs to stay compliant

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.

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08.01.20

Ph. Eur. Draft Chapter for PA Contaminants in Herbal Drugs

A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of  Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.

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04.12.19

FDA continues to warn companies for illegally selling CBD products

The FDA recently issued 15 warning letters to companies for illegally selling products containing cannabidiol (CBD).

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04.12.19

ICH Q12 adopted

The new ICH Q12 Guideline for Post-Appproval Changes has been adopted in Singapore in November 2019. The document provides guidance on a framework to facilitate the management of post-approval CMC changes.

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13.11.19

FDA works on regulatory pathways for CBD products

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.

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24.10.19

How to find the key to Ph. Eur. Monographs?

The Ph. Eur. provided a sample monograph to clearly show which information is included in and how to work with a Ph. Eur. monograph.

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09.10.19

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

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08.10.19

Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

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