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Membership & US Entry, GDPs, QRM Guidance and Traditional/Herbal Medicine Inspections Draw PIC/S Attention

FDA’s entry into the Pharmaceutical Inspection Cooperation Scheme (PIC/S) at the beginning of 2011 will be marked by the participation of Commissioner Margaret Hamburg at PIC/S’ upcoming 40th anniversary symposium on “Challenges and Future Perspectives” in Geneva, Switzerland in late May....

ASEAN Effort Progressing on CMC/GMP Harmonization, But Differences Remain

An analysis of the CMC/GMP regulatory framework among the Association of South East Asian Nations (ASEAN) shows significant progress in moving toward a more cohesive and harmonized approach, although differences remain in individual country requirements and procedures....

WHO Guideline on QRM Taking Shape

The World Health Organization (WHO) asked specific stakeholders in August to comment on a working draft of a detailed guideline it is preparing on the expectations for quality risk management (QRM) in pharmaceutical manufacturing. The guideline will update WHO’s advice to industry and regulatory bodies in the risk assessment area and align it with more recent documents published by other international regulatory authorities....

FDA Could be a PIC/S Member by Year’s End

The evaluation committee for the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is expected to recommend FDA’s acceptance into the 37-member organization at the next PIC/S meeting in Kuala Lumpur, Malaysia in November. Membership accession could follow by year’s end.

FDA and EMA Extend Confidentiality Agreement “Indefinitely”

FDA and the European Medicines Agency (EMA) are extending their confidentiality agreement covering information-sharing on human and veterinary medicine products “indefinitely without the need for further renewal” due to positive experiences by both agencies during the seven years the agreement has been in place....

Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....

FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

The EMA is continuing to seek drug manufacturers willing to participate in its joint inspection program with FDA for finished products. In an August 11 announcement, EMA explained that companies that have submitted two equivalent applications for the same product to both EMA and FDA can request to participate in the pilot....

ICH Q4B Annex 13 on Powder Density and Annex 14 on Bacterial Endotoxin Testing Out for Comment

FDA has made available for comment the Step 2 drafts of ICH Q4B Annex 13 covering the bulk density and tapped density of powders and Annex 14 on bacterial endotoxin testing. The drafts were cleared for release by the ICH Steering Committee meeting in June....

WHO Proposes New Guideline for Microbiology Labs and Adjustments to Site Master File, Water and HVAC Guides

WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and on heating, ventilation, and air-conditioning (HVAC) systems....

International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....
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