The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...

The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...

Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator. This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer compla...

The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos. The Regional Comprehensive Economic Partnership (RCEP) is a proposed free trade agreement (FTA) between the ten member...

Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. Following its r...

The US Food and Drug Administration’s (FDA) interest in rooting out data integrity deficiencies among Indian pharmaceutical manufacturers continued this month with a warning letter issued to Hyderabad-based Sri Krishna Pharmaceuticals. A lack of data audit trails, deleted sample data by a quality control analyst and loose computer controls that allowed analysts to manipulate data were all examples of issues cited by FDA officials from their inspection in December 2014. M...

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe. In February, ANSM inspected Anuh Pharma’s Maharashtra-based site and uncovered 24 deficiencies, including one that was critical and two that were major. The critical deficiency was linked to the fact...

The US Food and Drug Administration (FDA) has warned India-based Emcure Pharmaceuticals for repeated data manipulation and falsification. The warning letter, issued 3 March, follows an inspection at the company’s Hinjwadi-based site from 27 January to 4 February. The site has been banned from shipping products to the US since July 2015. Back in 2014, Emcure said it would hire a third-party auditor to conduct a comprehensive audit of all laboratory electronic and hard co...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Creates Priority Review Pathway for Cancer, Rare Disease Drugs The China Food and Drug Administration (CFDA) is creating a priority review pathway to cut the time it takes for some drugs to come to market. CFDA is aiming the initiative at products to treat certain significant illnesses and those that use advanced technology to deliver clear therapeutic benefits. In th...

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...

European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP. “The concerned API-batches or finished product containing the API should not be imported to the EEA [European Economic Area],” the agency said. “All API batches manufactured during the year 2014 are conce...

An article in The British Medical Journal ( BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times . FDA review staff noted their concerns about the drug's safety and efficacy, according to  The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding...