Pharmaceutical  News

(Regulatory)

March 2010

CEP News

• EDQM issued guidance documents for the submission of CEP applications in paper and electronic format.

  • Guidance for submission of electronic applications for CEP: Revised procedures.

  • Explanatory note: updated EDQM procedures related to paper and electronic submission for CEP applications.

• European Pharmacopoeia Commission adopted 10 new monographs, including three monographs on active substances

• New Expression of Acceptance Criteria in the Test for Related Substance.

Lab Compliance News

GMP News

• EMA Guideline for Stability Testing for Applications for Variations in revision

• MHRA Consultation Procedure for Strengthening Secure Supply Chains

• Deviations and CAPA most frequent observations in FDA inspections

• Microbiological Control of Herbal Drugs

• European QP Association Releases Database "QPSHARE"

• Final Annex 13 on Investigational Medicinal Products Published

• FDA publishes finalized Guidance for Characterization and Qualification of Cell Substrates and Other Biological Materials

• Central Anti-Counterfeit Laboratories - a Strategy to fight against Counterfeit Medicines

• HPLC in FDA Warning Letters 2009

• Q-and-A List by EMA on the Centralised Procedure Extended

• Memorandum of Understanding (MoU) signed between PIC/S and Russia

• Which Role Does the Rx-360 Consortium Play in the Fight against Counterfeit Medicines?

• FDA Director of Pediatric International Program to speak at ECA Development Conference

• EMA's Inspectors Working Group Publishes Work Plan 2010

• Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete?

• Current FDA Procedures for Counterfeit Medicines

• FDA to speak at ECA Development Conference on Quality by Design

• FDA announces new Programme for a more efficient Inspection of Imports

• EMA publishes "Draft Guideline on Validation of bioanalytical Methods"

  • Guide

•  Review of Supplement 6.8 European Pharmacopeia 6th Edition

USP News

• PF - Highlights - March- April 2010 (Vol 36, No.2)

• Errata - March - April 2010 (PF 36-2)

• IRA - March - April 2010 (PF 36 -2)

• Revision Bulletins - Methotrexate

• Glacial Acetic Acid: Notice of Intent to Revise

• New Pending and Non-US Monographs : Pending Monographs : Non-US Monographs

• Revisions to FCC Seventh Edition

•  USP-NF Recall Update: Third Public Notice 

Archived News