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IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

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 […]

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 […]
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