International Pharmaceutical Regulatory Monitor

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is taking issue with an EU plan to scan all drugs at the point of dispensing, saying the cost of providing scanners at all healthcare outlets is too burdensome.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled a new anti-counterfeiting strategy that builds off a 2007 strategy with increased international collaborations to fight the expanding risk of fake drugs online.

The European Medicines Agency must increase inspections of foreign trials and work with regulators and ethics bodies in other countries to ensure there is a robust framework for the oversight and conduct of clinical trials, a new EMA report concludes.

Full clinical trial reports with raw data should be publicly available, but regulatory authorities must develop engagement and standards to ensure that meta- and re-analysis of data are of high quality, a group of European regulators say.

Drugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says.

The European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.

Drugmakers should apply a lifecycle approach to process validation — tying together data on product and process development, the commercial manufacturing process and maintenance and consistency of the process during routine commercial production, according to the European Medicines Agency (EMA). Includes the full text of EMA Draft Guideline On Process Validation for Drugmakers.

The European Court of Justice has struck down a section of a 2001 Polish law that allows doctors and hospitals to import cheaper, unapproved drugs equivalent to drugs legally authorized in the Polish marketplace.

Companies with drugs authorized in the UK are being asked to update the Medicines and Healthcare products Regulatory Agency (MHRA) on the marketing status of their products.

To help drugmakers speed new therapies to patients with rare diseases, U.S. and EU regulators should harmonize their philosophies around orphan drug development and generate common guidance on trial requirements, experts say.

Patients with rare diseases in rural China and India are finding it increasingly difficult to obtain necessary medications, and both countries need to find ways to increase access to orphan drugs, experts say.

China’s State Food and Drug Administration (SFDA) instructed local regulatory authorities to shut down drug facilities manufacturing gelatin capsules contaminated with toxic levels of chromium.

Looking to increase pharmaceutical trade with the U.S. and improve its drug manufacturing standards, the South Korea Food and Drug Administration (KFDA) April 2 signed a memorandum of understanding (MOU) with the U.S. Pharmacopeial Convention (USP).

The South Korean Food and Drug Administration and Japan’s Pharmaceutical and Medical Devices Agency submitted applications for membership in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

As many as 33 new drugs approved for use in India between January 2008 and October 2010 — roughly one a month — never underwent clinical trials, according to a scathing parliamentary assessment of the Central Drugs Standard Control Organization (CDSCO) and its drug approval process.

Beginning Sept. 1, new drug applications to the Saudi Food and Drug Administration (SFDA) must include an electronically submitted non-electronic common technical document (CTD).

The U.S. Food and Drug Administration (FDA) and other agencies must provide expertise, training and tools to developing nations to improve their pharma monitoring practices and prevent dangerous drugs and medical products from entering the U.S., according to an April 4 Institute of Medicine (IOM) report.

Over the next several years, the U.S. Food and Drug Administration (FDA) will engage more with its international counterparts through systems that will allow it to share real-time information and resources in a more comprehensive way than is currently possible.