Regulatory News Archives 2007

December 2007

Argentina/ Iname & Malta (Medicines Authority) Join PIC/S (17 December 2007)
Argentina / INAME & Malta / Medicines Authority will join PIC/S as full Members on 1 January 2008.

China Issues Provisions For Drug Recall (14 December 2007)
According to the Provisions, drug recall means that drug manufacturers, including overseas manufacturers of imported drugs, recall the drugs with potential health hazards. The Provisions stipulates that recalls are classified into two categories and three levels for the purpose of risk control. The Provisions intensifies enterprise responsibility, and states that drug manufacturers should be the first to be held accountable for the safety of the drugs they sell. The Provisions specifies that overseas manufacturers of imported drugs have the same legal obligations as domestic drug manufacturers on drug recalls.

The ninth China Pharmacopoeia Committee EstablishedThe State Food and Drug Administration established the ninth China Pharmacopoeia Committee to compile the Pharmacopoeia of the People's Republic of China (2010 Edition.) and formulate and revise the National Drug Standards. (10 December 2007)

FDA Issues Direct Final Rule Amending Drug GMP Regulations (21 CFR Parts 210 and 211) (4 December 2007)
FDA is amending certain regulations as the first phase of an incremental approach to modify GMP regualtions for finished pharmaceuticals. The amendments modernize and clarify some of the GMP requirements, harmonize some with other foreign regulators and other FDA regulations, and are consistent with current industry practice.

PIC/S Press Release (4 December 2007)
The release provides updates on PIC/S activities including PIC/S Executive Bureau, PIC/S Committee, annual PIC/S Seminar, PIC/S – ASEAN forum and PIC/S – ISPE joint workshop. It is the first time that PIC/S meetings (including the annual PIC/S Seminar) have taken place in Asia.

FDA Faces Damning Report on Science Expertise (3 December 2007)
Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is underfunded for its vast responsibilities, an expert panel will tell the FDA on 3 December.

November 2007

FDA-EMEA Cooperation Intensified (26 November 2007)
This aims at simplifying the process of obtaining orphan status for medicines intended for rare diseases in both jurisdictions.
First MHRA Anti-Counterfeiting Strategy and New Counterfeit Reporting Hotline Launched (23 November 2007)
The first MHRA Anti-Counterfeiting Strategy has been published, setting out the MHRA's approach to combating the availability of counterfeit medicines and devices in the UK for the next three years.
MHRA Publishes Annual Report on Advertising and Six New Case Reports Published Today (21 November 2007)
This covers activities carried out by the Advertising Standards Unit in the year from September 2006 to August 2007 and contributes to the Agency's policy of transparency in the regulation of medicines advertising.
European Commission Publishes the Outcome of the Public Consultation on the Future of Pharmaceuticals (14 November 2007)
In July 2007, the Commission launched a public consultation on the future of pharmaceuticals for human use in Europe. You can find all public contributions to this consultation.
China's SFDA Issues Newly Revised Pharmaceutical GMP Inspection Standards (14 November 2007)
They further upgraded GMP inspection standards and intensified management. The Standards will be implemented as of 1 January 2008.
Press Release from ICH Yokohama Conference on "Modernizing the Manufacturing of Quality Pharmaceuticals" (13 November 2007)
A large range of ICH expert working groups met to progress their work. This included working groups on the safety reporting in clinical trials, electronic exchange of information the quality of medicines and non-clinical safety.
Waxman, Kennedy, and Allen Introduce Bill to Boost US FDA's Oversight of Over-the-Counter Drugs (9 November 2007)
This bill would permit FDA to act quickly to protect consumers from unsafe or ineffective over-the-counter drugs

October 2007

Health Canada Releases Final Good Guidance Practices Manual (31 October 2007)
This is the final version of the manual providing the definitions, procedures and practices for the development, issuance and use of the various documents that provide guidance to TPD and BGTD staff and stakeholders.
Second status report on the implementation of the EMEA Road Map (29 October 2007)
Reports on prgress made in 2006 and the first half of 2007
Gerald F. Masoudi Named FDA Chief Counsel (16 October 2007)
Masoudi has been appointed as associate general counsel/chief counsel of the Food and Drug Division of the United States Department of Health and Human Services' Office of the General Counsel, which handles legal matters for the U.S. Food and Drug Administration.
Health Canada Publishes Inspection Strategy for Blood and Source Plasma Establishments (POL-0039) (1 October 2007)