China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA. The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the rat...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Hepatitis C, Cancer Drugs on Regulatory Approval Fast Track China has granted priority review status to a clutch of drugs being developed by Western companies. The products affected by the actions include the expensive hepatitis C drugs from Gilead Sciences and other manufacturers that have transformed treatment of the disease in the West. Versions of Gilead’s b...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Drug Safety and Traceability at Forefront of Healthcare Reform Program China has committed to bolstering the safety controls and traceability requirements that cover its local drug market. The commitment, which was made at a meeting of the State Council, is part of a raft of healthcare reform initiatives that are collectively intended to lessen China’s reliance ...

As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India. A Focus review (thanks to use of the Freedom of Information Act (FOIA)) of eight FDA Form 483s for Chinese manufacturers i...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pharmacy Sues CFDA Over Alibaba Electronic Drug Monitoring System Yontinhe Group has filed a lawsuit against the China Food and Drug Administration (CFDA). The case relates to an electronic drug monitoring system that CFDA introduced in 2013 in collaboration with a subsidiary of the Chinese tech giant Alibaba. CFDA and Ali Health, the Alibaba subsidiary, purportedly ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign drugmakers, the highest profile of which is India’s Aurobindo Pharma. The regulator framed the warnings as part of an initiative to step up its oversight of companies that are importing ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Sanofi Secures Indian Committee Approval for Dengue Vaccine Without Local Phase III Data An Indian drug regulatory committee has recommended allowing Sanofi to bring its Dengue vaccine to market without first generating Phase III data in a local trial. The committee thinks the divergence from normal protocol is acceptable given the scale of the health threat posed by the D...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Moves Back Deadline for Implementation of Track and Trace India has pushed back the deadline by which manufacturers must comply with aspects of its system to track and trace drug exports. Having originally set a deadline of July 2015, the government has now once again delayed the date on which the export monitoring system must be implemented. The Directorate Genera...

The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there. The agency has already detected hydrogen cyanide contamination in two shipments of drugs from Tianjin-based Tianjin Tianyao Pharmaceuticals Co., approximately 30 kilometers (18 miles) from the explosion site. The contaminated sh...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Pushes to End Regional Variation in Strength of Clinical Trial Oversight The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality. CFDA began its clam...

Welcome to our Asia Regulatory Roundup, a weekly overview of the top regulatory news in Asia . Fresh Batch of Withdrawals and Rejections Chips Away at CFDA Backlog China Food and Drug Administration (CFDA) has wiped almost 150 drug filings from its backlog. Most of the applications were pulled by the companies themselves, with CFDA only actively rejecting 13 of the submissions. The withdrawals affected 131 filings by 82 companies. CFDA put pressure on companies ...