International Pharmaceutical Regulatory Monitor

Several pharma companies are defending their decisions to end discount prices for HIV drugs in middle-income countries following criticism from Doctors Without Borders (DWB).

Health ministers of the BRICS countries (Brazil, Russia, India, China and South Africa) are collaborating to address trade barriers and other challenges to healthcare product access in the regions.

Two inspection pilot projects involving the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are getting results and should be expanded, according to reports issued Aug. 2 on the programs — one on active pharmaceutical ingredient (API) inspections and the other involving clinical inspections. Includes the full text of Final Report on the International API Inspection Pilot Programme.

U.S. legislators are divided on whether to propose 12 years of exclusivity for biosimilars in the Trans-Pacific Partnership (TPP) negotiations, and two sets of representatives have sent letters to President Barack Obama pushing opposing views.

The U.S. user fee for a new drug application requiring clinical data will cost more than $1.8 million beginning Oct. 1 — an increase of 19.42 percent from last fiscal year.

The European Commission (EC) is tightening supply chain guidelines, requiring pharmaceutical distributors to audit and approve transportation hubs where the products are loaded and reloaded.

Pay-for-delay deals are on the decline in the EU but patent settlements as a whole were on the rise last year, according to the European Commission (EC).

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending new warnings for pioglitazone Type 2 diabetes drugs, but says the benefits outweigh a small risk of developing bladder cancer.

The UK government will begin negotiating a new value-based pricing (VBP) system for pharmaceuticals in 2012 but some warn the system might cause problems, including reduced incentives for early UK launches.

Drug manufacturers in New Zealand and Australia will be able to submit one patent application for simultaneous review in the two countries beginning in 2013.

New Zealand is bringing its rules for pharmaceutical labeling and advertising requirements into closer alignment with Australia’s in advance of the pending joint regulatory agency.

Review, application and registration fees for medical devices and medicines in Australia are increasing by 3.4 percent.

Medicines Australia is seeking Senate help in convincing the government to list new medicines on the Pharmaceutical Benefits Scheme (PBS) after it recently deferred listing eight new medicines due to financial reasons.

All drug sponsors reporting adverse events in Australia must use terminology from the Medical Dictionary for Regulatory Activities (MedDRA) beginning Oct. 1, as part of a move toward faster adverse event analysis.

Australia’s Therapeutic Goods Administration’s (TGA) transparency review panel is calling on the agency to take several steps toward greater transparency, including developing an early postmarket risk communication scheme and creating an online tracking system for applications.