Article archive

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017

23/04/2017 18:47
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017Eleven medicines recommended for approval, including four orphansThree recommendations on extensions of therapeutic indicationsWithdrawal of applicationOthersFor completehighlights, ClickHere.

Recognition of Alternative Compendia (BP/EP/JP) by the FDA

23/04/2017 18:43
The Office of Pharmaceutical Quality within FDA's Center for Drug Evaluation and Research (CDER) published a new edition of the document "MAPP (Manual of Policies and Procedures) 5310.7 - Acceptability of Standards from Alternative Compendia (BP/EP/JP) on 30 January 2017. The main change to the...

EMA revises Guide on Pharmaceutical Water

23/04/2017 18:40
According to the European Pharmacopoeia, it will be allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods (as already reported under "WFI obtained by non-distillation methods - What are the Next Steps?"). Now, the European Medicines Agency...

GCP - Implementing Regulation on Inspection Procedures

23/04/2017 18:37
The Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 was published on 25 March 2017 in the Official Journal of the European Union. With it, Article 63 of the GCP...

EMA Q&A on GCP

23/04/2017 18:37
The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website.Question 8 regarding contractual arrangements with vendors for electronic systems under "GCP matters" Q&A  (please see below) has been published in January 2017...

MHRA's Interpretation of Cross Contamination & PDEs

23/04/2017 18:36
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be applied. One essential element of that concept is EMA's Q&A Paper describing when a product should be...

Packaging: Pharmeuropa Draft Chapters regarding PVC

23/04/2017 18:34
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of di(2-ethylhexyl)phthalate as a substance of very high concern (SvHC) according to the criteria of Article 57 of regulation (EC)...

Best Practice Guide for Quality Agreements published

02/02/2016 23:58
In the EU GMP Guide Chapter 7 on Outsourced Activities, expectations regarding quality contracts are clearly defined. In the US, not much detail was provided so far. In 2013, the U.S. Food and Drug Administration (FDA) has published the draft Guidance for Industry "Contract Manufacturing...

ISO 14644 - Part 1: Final Version on Cleanroom Classification

02/02/2016 23:54
Part 1 of ISO 14644 entitled "Classification of air cleanliness by particle concentration" is one of the most  important norms in the GMP environment as it is the only technical norm which is directly referred to in an official GMP guideline document: the currently applicable Annex 1...

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

02/02/2016 23:50
A chemical structure with a therapeutic moiety for which no authorisation dossier has been submitted so far and which is - from a chemical structure point of view - not related to any other authorised substances is per se a "NAS" (New Active Substance). But what about a...
Items: 31 - 40 of 337
<< 2 | 3 | 4 | 5 | 6 >>