European Commission Launches Public Consultation on GMP Guide Revision
Health Canada Notification: Release of Final Versions of Documents - Drug Good
Manufacturing Practices (GMP) Inspection Program (7 August 2009)
Three final GMP guidelines have been released.
Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program
(GUI-0001 related)(7 August 2009)
Five draft GMP guidelines have been released for comment.
Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection
Program (7 August 2009)
Two draft GMP guidelines have been released for comment.
FDA Commissioner Sets Out Vision on Enforcement to Support Public
Health (6 August 2009)
Dr. Hamburg discusses her plans to create a strong FDA that is vigilant, strategic, quick, and visible in its
enforcement activities.
Health Canada Publishes the Following Documents: (3 August 2009)
- Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)
- Good Manufacturing Practices - Audit Report Form (FRM-0211)
- Good Manufacturing Practices - Audit Report Form (FRM-0211) Instructions
- Good Manufacturing Practices - Foreign Site Submission Form (FRM-0212)
- Good Manufacturing Practices - Request for an Inspection of a Foreign Site Form (FRM-0213)
- Good Manufacturing Practices - Foreign Site Inspection Services Agreement Form (FRM-0214)
US FDA, European Medicines Agency Launch Good Clinical Practices
Initiative (3 August 2009)
The U.S. Food and Drug Administration and the European Medicines Agency (EMEA) announced an agreement to
launch a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials
submitted in drug marketing applications in the United States and Europe are conducted uniformly,
appropriately and ethically. The initiative will begin with an 18-month pilot phase on September 1, 2009 and
will focus on collaborative efforts to inspect clinical trial sites and studies. Products regulated by the
FDA’s Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union
will be the focus of the initiative.
The Quality Implementation Group on Q8-Q9-Q10 has released a new set of Q&As that were
signed in Yokohama, Japan, June 6-11. (31 July 2009)
Provides the most up to date answers on commonly asked questions on Q8, Q9, and Q10.
Australia's TGA Publishes Updated manufacturing principles for medicinal products (31 July 2009)
On 29 July 2009 the TGA National Manager determined new principles to be observed for manufacturers of
medicinal products (including active pharmaceutical ingredients and sunscreen products) under Section 36(1)
of the Therapeutic Goods Act 1989. Therapeutic Goods (Manufacturing Principles)
Determination No 1 of 2009 brings Australian manufacturing requirements into line with current
international practices by adopting the Guide to Good
Manufacturing Practice for Medicinal Products issued by the Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Co-operation Scheme (PIC/S) in January 2009. The PIC/S Guide also incorporates the
ICH Harmonised Tripartite Guideline Good Manufacturing Practice for Active
Pharmaceutical Ingredients.
US
GAO: FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop
Complete Estimates of Its Resource Needs (20 July 2009)
FDA faced challenges fulfilling and managing its growing medical product oversight responsibilities, which
agency officials attributed to resource constraints. FDA’s statutory responsibilities grew during this period
and a growing number of medical products subject to FDA oversight and establishments manufacturing these
products for the U.S. market also added to the agency’s workload. However, FDA could not provide data showing
its workload and accomplishments in some areas, such as its review of reports identifying potential safety
issues with specific medical products. Without such information, FDA cannot develop complete and reliable
estimates of its resource needs. While FDA officials said that the funding amounts requested for and provided
to FDA during the past 2 years will permit the agency to respond to its most urgent needs and priorities,
officials also noted that they did not receive enough resources to meet some statutory requirements, such as
biennially inspecting certain manufacturing establishments. Furthermore, officials said that the agency faces
significant challenges fulfilling its mission to oversee the safety and effectiveness of medical
products.
China launches more special programs to ensure drug safety (17 July 2009)
In order to ensure medicinal safety, more special programs recently launched in China. The special programs
will be last about 2 years, which are conducted by six related ministries and commissions including the
Ministry of Health, the Ministry of Public Security, the Ministry of Industry and Information, the State
Administration of Industry and Commerce, the State Food and Drug Administration, and the State Administration
of Traditional Chinese Medicine.
Annual
Report of the European Medicines Agency 2008 (10 July 2009)
This report provides an extensive overview of the substantial activities of the EMEA during the year 2008.
The reader will see that all of the core business activities in the EMEA saw substantially increased activity
during the year, including a 14% increase in applications for scientific advice, a 20% increase in individual
case safety reports reported through EudraVigilance, a 30% increase in the number of GMP inspections and a
60% increase in the number of GCP inspections, to mention but a few. There was also substantial activity in
the area of paediatric implementation plans and slow but steady progress in the area of finalising herbal
medicines monographs. Evaluation of veterinary medicines was at an equivalent level to the 2007 activities. A
new committee, the Committee for Advanced Therapies, was established and I welcome the members and wish their
activities every success. An advisory group was established for the EMEA involvement in the implementation of
ENCePP.
Temporary cessation of the working process in the Bulgarian Drug Agency in
August 2009 (8 July 2009)
The Bulgarian Drug Agency would like to inform all parties concerned that in the course of August 2009 a move
into the new building with administrative address 8 “Damyan Gruev” str. is to take place.
From 3rd of August until 31st of August 2009, the reception and the granting of any documents, which concern
procedures for marketing authorization of medicinal products, renewals, variations, etc. will be
ceased. Due to moving the BDA servers, connection to the computer system and EudraNet connection will
be temporarily unavailable for the period 10.08 – 21.08.2009.