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Pakistani Supreme Court Orders Creation of National Drug Regulatory Authority

In early February, the Pakistani Supreme Court directed the federal government of Pakistan to establish a “Drug Regulatory Authority” within 10 days, after it was informed that five countries had banned the import of Pakistani medicines after the deaths of over 135 patients in Pakistan as a result of contaminated drugs, according to The News […]

GMP Consent Decrees Do Not Delimit Litigation and Financial Risks, Skadden, Arps Partner Stresses at FDLI Conference

Consent decrees provide a resolution between FDA and a pharmaceutical manufacturer of the cGMP compliance commitments and non-conformance penalties but do not forestall other types of litigation and generally have a long tail of related liabilities and financial repercussions, Skadden, Arps, Slate, Meagher & Flom Partner Jennifer Bragg stressed at the annual Food & Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference in Washington, D.C. in December....

Ranbaxy Consent Decree Fires FDA Warning Shot for Ex-US Pharma on Data Integrity

The consent decree signed between Indian generic drug manufacturer Ranbaxy and the US Department of Justice (DoJ) serves as a warning shot across the bow for companies supplying to the US market that FDA findings of falsified information in applications or CGMP records will have very substantial consequences....

China Seizes $315M in Counterfeit Drugs and Arrests 1,770 Suspects

Chinese police seized two billion yuan ($315-million) in counterfeit drugs and arrested over 1,700 suspects in a nation-wide crackdown on fake medicines in late November, according to the international news organization AFP. AFP cited a press release from China’s Ministry of Public Security, which stated that over 1,400 “dens” that made or sold counterfeit medicines […]

PDG Advances International Pharmacopeial Harmonization Effort

In mid-November, the European Directorate for the Quality of Medicines (EDQM) reported that the Pharmacopeial Discussion Group (PDG) has completed harmonization of 28 of the 35 General Chapters and 41 of the 61 excipient monographs in its current work program. Formed in conjunction with ICH, the members of the PDG are the European Pharmacopoeia (EP), […]

EDQM Publishes First Monthly Report on Certification of Substances

The European Directorate for the Quality of Medicines (EDQM) has published its first monthly report on the Certification of Substances Division (DCEP) The September report notes that the DCEP received 32 new certification (CEP) requests in September and approved 20.  It also received 122 revisions, including notifications and renewals, and suspended or withdrew five CEPs. […]

Current Staffing Levels at China’s SFDA May Hinder QbD Submissions; Investigational-Stage Changes and Timelines Also at Issue

International pharma is expressing concern that the ability to put ICH Q8-10 principles into practice in China is hampered by the significant limitations in its current review manpower....

China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....

Draft “DMF” Regulation in China Draws International Pharma Attention

The filing requirements China is proposing for active pharmaceutical ingredients (APIs) and pharmaceutical “auxiliary materials” – including their mandatory nature and the lack of clarity regarding how changes to the filings will be handled – are areas of concern in international pharma’s assessment of the country’s evolving CMC program....

China’s SFDA Begins Inspections of Overseas Manufacturers

China’s State Food and Drug Administration (SFDA) is initiating inspections of pharmaceutical manufacturing facilities overseas that sell products in China as part of its ongoing effort to modernize and harmonize regulatory practices with international standards and ensure the quality and safety of medicines sold in its country.
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