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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

International Counterfeit Medicines Effort

In Mid-June, FDA, in partnership with international regulatory and law enforcement agencies, took action against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide. […]

WHO Guideline for Hold-Time Studies

The World Health Organization (WHO) released a final guideline on “storage and transportation of time- and temperature-sensitive pharmaceutical products.” Included is guidance on storage conditions for raw materials, packaging materials, intermediate, bulk and finished products, and on maximum hold-times for intermediate and bulk products prior to their further processing.

Indian Agency Counterfeit Drug Effort

India’s Central Drugs and Standard Control Organization (CDSCO) is in the process of sampling drugs on the market in India to determine what percentage of those are counterfeit, Indian Express reports. To date, about 50,000 samples from Indian manufac-turers have been collected. CDSCO plans to issue a report on the effort by the end of […]

APIs from Indian Firm Banned in EU

A Slovenia inspection team representing EMA discovered issues at Polydrug Laboratories in Maharashtra, India that have led to suspensions of all of the firm’s CEPs. According to the EudraGMDP report, 17 deficiencies were found, including five “major” deficiencies, involving: ● customer complaints “deliberately” unregistered in the official logbook ● storage of quality documents in an […]

EU Bans Sterile APIs from Chinese Firm

An April inspection of a Zhuhai United Laboratories sterile API site in Guangdong, China by Romanian inspectors representing EMA has resulted in some of the firm’s amoxicillin products being banned from sale in the EU. The firm claims to be the world’s largest manufacturer of the API for the antibiotic amoxicillin. According to the inspection […]

FDA Trip to China

In an FDA blog post, Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg, Center for Drug Evaluation and Research (CDER) Deputy Director Richard Moscicki, and Office of Regulatory Affairs (ORA) Pharmaceutical Quality Program Acting Director Alonza Cruse report on a recent trip they made to China. During the trip, the senior FDA officials […]

India Drug Regulator Upgrades and Rename

India’s drug regulator, the Central Drug Standard Control Organization (CDSCO) has made a proposal to the government’s cabinet of ministers to upgrade the agency’s regulatory oversight using the US FDA as a model, and will rename it the Central Drug Administration (CDA), the Hindustan Times reported. The draft note also suggests that CDA should fall […]

Indian Agency Adding Inspectors

In late June, India’s Central Drug Standards Control Organization (CDSCO) announced that it will add 147 drug inspectors by the end of 2015 to shore up its GMP inspection capabilities, PharmaBiz reports. It notes that “CDSCO expects to double the manpower and enhance the lab infrastructure both at the center and states by the end […]

Supply Chain Security Pilot Program

In Mid-May, FDA announced that is looking for firms capable of developing and implementing a pilot program to “explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain” in accord with the Drug Supply Chain Security Act (DSCSA). The announcement is not a solicitation for applications, but rather an attempt […]
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