GMP News - Pharmaceutical Development / Clinical Trials / GCP


New Toxicological Data on Isopropylbenzene Trigger its Categorisation as Class 2 Solvent

Due to new toxicity studies in rats and mice, the solvent Isopropylbenzene is meant to be categorised as Class 2 instead of Class 3. A corresponding ICH draft guideline has been published and released for commenting by the public. Here you will find the details.



Impurities and Setting Specifications - the EMA Publishes Harmonised Policies on Its Q&A Page

Impurities, like heavy metals, residual solvents and genotoxic substances, may have to be included in the drug substance specification depending on the point in time when they are formed or introduced into the synthesis process of an active pharmaceutical ingredient. On this issue, the EMA has described a harmonised policy on its Q&A page. Read more here.



EudraCT Version 8.0 and new CTA Application Form will go into production soon

The EU Commission has announced that EudraCT Version 8.0 will go into production on 7 September 2010. Read more.



Stability of Pharmaceutical Bulk Products - Which Data Are Dossier-Relevant?

The relevant guidelines on stability testing of active pharmaceutical ingredients and finished medicinal products provide hardly any information on the stability data of pharmaceutical bulk products that have to be included in the dossier for a marketing authorisation. Now the EMA gives answers to the most important questions in its Q-and-A section. Read more here.



WHO publishes new Guideline for the preparation of a CRO Master File

With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also published a new Annex 7 "Guidelines for the preparation of a contract research organization master file". Read more.



Authority Statement on Validation in Pharmaceutical Development

The Danish Medicines Agency (DKMA) is running a web page on FAQs on Annex 13 of the EU GMP Guide (Manufacture of investigational medicinal products). One interesting Q&A is dealing with validation of critical manufacturing processes. Read more.



Revised Annex 13 on Investigational Medicinal Products (IMP) coming into operation

The European Commission has published on the EudraLex - Volume 4 webpage the new Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice. The new Annex is coming into force in July 2010. Read what's new.



EMA Draft Guideline open for Comments: Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses in Cell Culture

To provide guidance  to manufactueres of influenza vaccines on the quality issues associated with isolating candidate vaccine viruses in cell culture, the EMA lays down the quality recommendations for cells used to isolate candidate influenza vaccine viruses in a new draft guideline, which is open for consultation until September 2010. More information can be found here.



Clinical Trials: new Document for public Consultation

The European Commission has published a public consultation document: Draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ('CT-3'). Read more. 



Clinical Trials: FDA proposes new Data Falsification Rule

The FDA proposed an updated regulation to require sponsors to report information pertaining to any individual that has or may have engaged in falsification of data in clinical trial studies involving human or animal subjects. Read more.



Regulation amending the REACH Annexes relevant for SDS (Safety Data Sheet)

The Commission has adopted a Regulation amending the REACH Annexes relevant for SDS – Annex II and, to a lesser extent, Annex VI. Click here to read more.



Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials

The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 6.0 of this document is available here.



EMA publishes Reflection Paper on ethical and GCP Aspects of Clinical Trials conducted in third Countries

The European Medicines Agency has published for public consultation a reflection paper on ethical and GCP aspects of clinical trials conducted in third countries for evaluation in marketing authorisation applications for medicines for human use, submitted to the EMA. Read more.



Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC

Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC: summary of responses to the public consultation paper published. Read more.



FAQs on the EMA-FDA GCP Initiative published

The EMA and the FDA have published a set of Q&As on their new GCP-Initiative. Read more.


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