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".


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.


Hard Brexit: UK amends GDP Regulations

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


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?


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".


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".


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?


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.


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.


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.


Safety Features: Handling of Alerts

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


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.


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.


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.


MHRA Pharmacovigilance Inspection Metrics

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


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.


Hard Brexit: UK amends GMP and GDP Regulations

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


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.


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.


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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