GMP News - Regulatory Affairs

01.06.18

Brexit: UK commits to align with EU rules on clinical trials

The UK Government recently confirmed that it is committed to implementing the EU CTR into UK law to the extent possible after Brexit.

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01.06.18

New FDA Guidance on Liposomes

The FDA recently published its final guidance on liposomes. Read more about the authority's guidance for industry on Liposome Drug Products.

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16.05.18

Quality Risk Management is getting more and more important

QRM is becoming more and more appreciated and implemented through guidance like the EU-GMP Guidelines and ICH Q8 - Q12. And Quality Risk Management is much more than merely FMEA.

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09.05.18

Regulatory classification of API co-crystals in the US Approval Procedure

To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.

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25.04.18

Brexit: EMA appoints new rapporteurs for centralized authorizations

In the course of Brexit, the EMA has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. Read more about EMA's procedure for appointing new rapporteurs.

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03.04.18

EMA: HMPC Meeting Report published

On 27 November, 2017, the EMA's Committee on Herbal Medicinal Products (HMPC) published the HMPC meeting report about their 79. meeting held from 20-21 November, 2017. Learn more about the key issues discussed during the EMA HMPC meeting.

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15.03.18

Warning letter: falsified batch records and missing certificates of analysis

The final release of drug products without the documented prove of compliance with the specifications is a criterion for exclusion, and not just during an FDA inspection. Find out, what other GMP violations regarding the manufacturing and testing FDA inspectors found during an inspection.

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15.03.18

More stringent FDA requirements for homeopathic medicinal products

In December 2017, the FDA published a new draft guideline for homeopathic products. There is to be a more stringent and risk-based approach by which all products are to be recorded. Find out more about the new FDA requirements for homeopathic products.

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08.03.18

EMA Committee for Advanced Therapies (CAT) publishes 2018 Work Plan

Concerning their activities in the field of ATMP, the EMA Committee for ATMP (CAT) published their work plan for 2018 for the different areas of responsibility from pre-authorisation to used technologies.

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08.03.18

CAT and CHMP update their Procedural Advice on the Evaluation of ATMPs

Relating to the ongoing experiences in the marketing authorisation of ATMPs, the EMA published an updated version of their "Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".

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21.02.18

EMA publishes ICH Q12 Draft with Deadline for Comments

The EMA issued the draft of the Guideline ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management and its Annexes for commenting.

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20.02.18

FDA Draft Guideline on reporting Changes to an approved Application

At the end of last year, the FDA published a revision draft for their guideline "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products" which is supposed to take account of the current standards of risk assessment and the submitted data of past change notifications.

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29.01.18

Annual report of the GCP Inspectors Working Group published

The annual report 2016 of the GCP Inspectors Working Group (IWG) has been published. According to the report EU inspectors have found more than 1000 clinical trial deficiencies in 2016. Read more about the Annual report of the Good Clinical Practice Inspectors Working Group 2016.

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29.01.18

USP proposes additional changes to <1090> Assessment of Drug Product Performance

Additional changes to the USP general chapter <1090> have recently been proposed by the USP General Chapters—Dosage Forms Expert Committee. Read more about the revision of USP chapter Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution.

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24.01.18

PSURs: EMA revises Post-Authorization Procedural Advice

The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).  

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