GMP News - Regulatory Affairs

03.04.19

Brexit: MHRA clarifies UK PV rules for the no-deal scenario

The MHRA recently published guidance on QPPVs, PSMFs and MHRA PV registration in the event of a no-deal Brexit.

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21.03.19

FDA´s Pilot Program for Established Conditions

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

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20.03.19

Focus on Cannabis in INCB´s Report for 2018

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

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20.03.19

Current Q&A on the MRA EU-FDA

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

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06.03.19

Brexit: Handling Pharmacovigilance Data from the UK

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

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27.02.19

Brexit: Will UK Inspection Reports and GMP Certificates still be valid?

Will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority? The answer is yes - but with restrictions.

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26.02.19

MHRA Pharmacovigilance Inspection Metrics

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018. 

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14.02.19

Radiopharmaceuticals - Draft Guideline on non-clinical Requirements

In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".

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14.02.19

ICH´s Approach for Harmonization of Standards for Generic Drugs

The International Council for Harmonization (ICH) recently published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".

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30.01.19

Hard Brexit: UK amends GMP and GDP Regulations

To face a possible Hard Brexit, UK plans to amend EU GMP Guidance.

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30.01.19

EMA publishes comments on ICH Q12

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.

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24.01.19

EMA Guideline on Content, Management and Archiving of the TMF

The EMA published a new guideline on the content, management and archiving of the TMF clinical trial master file (paper and/or electronic).

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24.01.19

When does one speak of a "true" First in Human trial?

A new post, "Is it really a First in Human trial? Categorizing and assessing the risks correctly" has just been published on the MHRA Inspectorate blog.

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24.01.19

Clinical Trials if there is no Brexit Deal

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.

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23.01.19

Swissmedic Document on the Role of the RP in Contract Manufacturing

The Swiss authority Swissmedic has published a new auxiliary document for the so-called "RP Declaration".

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