With such rapid changes taking place, it is important to stay abreast of the latest developments in the Pharmaceutical industry. Below is a selection of useful news items, this page is updated regularly so be sure to check back or add this as bookmark.

Recent Changes

NEW! The European Commission have issued a new document for public consultation on the Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use. The deadline for comments is 31 Dec 2011 (click here) Issued 15 Jul 2011

NEW! A new EU Directive on the Falsification of Medicines, amending 2001/83/EC,  has been published in the Official Journal (Dir 2011/62/EU) Issued 01 Jul 2011

NEW! The EMEA have issued 'Internationally Harmonised Requirements for Batch Certification' (EMA/INS/MRA/387218/2011 rev5) Issued 01 Jun 2011

NEW! ICH have issued a new DRAFT guideline for public consultation: ICH Q11 entitled 'Development and Manufacture of Drug Substance (Chemical entities and biotechnological/ biological entities)'  Deadline for comments Sep 2011 (via EMA) Issued 19 May 2011

NEW! The European Commission guidance document on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPS) has been updated (click here) Issued 01 Mar 2011

NEW! The FDA have issued a new Guidance for Industry entitled 'Process Validation: General Principles and Practices' (click here)

NEW! Annex 11 (Computerised Systems), to the EU Guide to GMP has been updated and is effective 30 Jun 2011 (click here)

NEW! Chapter 4 (Documentation), to the EU Guide to GMP has been updated and is effective 30 Jun 2011 (click here)

NEW! The EMA have issued a DRAFT template entitled 'Template for the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain "The QP declaration template" (EMA/CHMP/CVMP/QWP/696270/2010), the deadline for comments is 30 Apr 2011

NEW! The EMA have issued a DRAFT Q&A paper on the above mentioned "QP declaration template" (EMA/CHMP/CVMP/QWP/696305), the deadline for comments is 30 Apr 2011

NEW! The EMA have published a new document: 'ICH Q8, Q9, Q10 Questions and Answers, volume 4'  (EMA/CHMP/ICH/265145/2009)

NEW! The US FDA and UKRAINIAN SIQCM are to join PIC/S. At its last meeting in Kuala Lumpur (Malaysia) on 8-9/ November 2010, the PIC/S Committee invited the US Food and Drug Administration (FDA) and the Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM) to join the Pharmaceutical Inspection Co-operation Scheme as from 1 January 2011 (for more information click here)

NEW! A draft concept paper on a proposed revision to Chapter 6 of the EU GMP Guide, entitled 'Quality Control'  has been issued for public consultation; deadline for comments is 28 Feb 2011 (EMA/INS/GMP/632654/2010)

NEW! A draft concept paper on storage conditions during transit has been issued for public consultation; deadline for comments is 28 Feb 2011 (EMA/INS/GMP/638479/2010)

NEW! A proposed revision to Chapter 5, entitled 'Production', has been issued for public consultation; deadline for comments is 28 Feb 2011 (click here)

NEW! A proposed revision to Chapter 7, entitled 'Outsourced Activities', has been issued for public consultation; deadline for comments is 28 Feb 2011 (click here)

The EMA/ FDA have announced a joint GMP inspection pilot programme (EMA/660312/2010)

The EMA have adopted the Guideline on Minimum Quality and Non-Clinical Data for Certification of Advanced Therapy Medicinal Products (EMA/CAT/48683/2008/corr)

The EMA have published a DRAFT reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010), deadline for comments 28 Feb 2011

The WHO have revised their guidelines on GDP (Annex 5) as part of their update to the WHO Technical Report Series No. 957, 'Specifications for Pharmaceutical Preparations'

The EMA have adopted the guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines (EMA/CHMP/VWP/141697/2009) which comes into effect on 01 Jan 2011

The EMA has issued a reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (EMA/INS/GCP/454280/2010)

UK Statutory Instrument 2010 No. 1882 'The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations' has been issued (Jul 2010)

The CHMP has adopted the reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors EMEA/CHMP/GTWP/587488/2007rev1 (Jun 2010)

The MHRA has issued updated guidance on the use of UK contract laboratories (click here) (Jun 2010)

The MHRA have updated their policy on 'Returns of non-defective refrigerated medicinal products' (Apr 2010)

The FDA have issued a new Guidance for Industry entitled, 'Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages' (Mar 2010)

The FDA have issued a new Guidance for Industry entitled, 'Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format' (Mar 2010)

Annex 13 to the EU Guide to GMP, 'Manufacture of Investigational Medicinal Products' has been updated & is effective from 31 July 2010 (Feb 2010)

Part II to the EU Guide to GMP, 'Basic Requirements for Active Substances used as Starting Materials' has been updated & is effective from 31 July 2010 (Feb 2010)

Annex 6 to the EU Guide to GMP, 'Manufacture of Medicinal Gases' has been updated & is effective from 31 July 2010 (Feb 2010) 

PIC/S Technical Interpretation of the Revised Annex 1 PI 032-2 (Jan 2010)

The scope of the EC-Switzerland Mutual Recognition Agreement (MRA) has been extended to include Advanced Therapy Medicinal Products (ATMPs) EMA/825063/2009 (Jan 2010)

The MHRA GDP Inspectorate have issued an updated policy on 'Returns of non-defective medicinal products' (Oct 2009)

ICH Considerations: General Principles to Address Virus and Vector Shedding EMEA/CHMP/ICH/449035/2009 (July 2009)

The MHRA has published a document entitled 'Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples (click here) (July 2009)