GMP NEWS 2019

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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FDA: New Steps to improve Supply Chain Security

The US Food and Drug Administration (FDA) is launching a new pilot project for enhanced tracing and verification approaches in the pharmaceutical distribution supply chain.

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Hard Brexit: UK amends GDP Regulations

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

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Blockchain - what is it about?

Blockchain should be able to help solve the challenges of the increasingly complex sales system. But what is Blockchain anyway?

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FDA Guideline on Immunogenicity Testing of Therapeutic Protein Products published

In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".

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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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Current Activities of the GDP Association

The European GDP Association is quite active in supporting its members. What has been achieved in the past six months?

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EU-FDA MRA: Soon all States on board

The MRA with the USA was supplemented by two further countries: Poland and Slovenia. However some are still missing.

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Quality Metrics: More than an FDA Initiative

Quality Metrics can support both companies and regulators to guarantee a high quality performance and the continuity of quality product supply.

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WHO and IAEA - Draft Guideline on GMP for Radiopharmaceuticals

In January 2019, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft guideline dealing specifically with the GMP requirements for the manufacture of radiopharmaceuticals.

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Safety Features: Handling of Alerts

The safety feature provisions enetered into force - How to report a falsified pack?

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US Track and Trace System

The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.

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Current Questions and Answers on Data Integrity and Audit Trail Review

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.

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Brexit: OMCL Release Decisions still valid?

What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer.

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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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EMA starts moving to Amsterdam

The European  Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.

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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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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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Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.

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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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