Registration News

The sources of information are: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Prod, Ministry of Health, Main Pharmaceutical Inspectorate, European Medicines Agency (EMEA), European Commission – Enterprise and Industry, European Directorate for the Quality of Medicines & Healthcare, EudraLex,, U.S. Food and Drug Administration (FDA), The Medicines and Healthcare products Regulatory Agency (MHRA) and other European Agencies.

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2012-02-02
EMA: Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

2012-02-02
GMP: Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure

2012-02-02
GMP: Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment

2012-01-26
EMA: Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

2012-01-26
EMA: Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products

2012-01-26
EMA: Draft guideline on active-substance-master-file procedure (revision 3)

2012-01-26
EMA: Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man

2012-01-26
EMA: Draft guideline on the approach to establish a pharmacological acceptable daily intake

2012-01-19
EMA: Guideline on similar biological medicinal products containing interferon beta

2012-01-19
EMA: Guideline on the evaluation of anticancer medicinal products in man

2012-01-19
EMA: Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs for treatment of rheumatoid arthritis

2012-01-12
EMA: Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

2012-01-12
EMA: Public consultation opens on the revised guideline on the evaluation of human anticancer medicines

2012-01-12
IPEC: Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients

2012-01-05
EMA: New measures to facilitate conduct of ENCePP studies

2012-01-05
FDA: Use of Histology in Biomarker Qualification Studies

2011-12-22
EMA: European Medicines Agency issues revised guidance on genotoxicity testing of medicines

2011-12-22
EMA: Committee on Herbal Medicinal Products approves four-year work programme

2011-12-22
EMA: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines

2011-12-22
GMP: New FDA and EMA Initiative allows mutual Recognition of Inspections

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