International Pharmaceutical Regulatory Monitor

Almost doubling its market share from five years ago, global spending on generic drugs will jump to 39 percent of all pharmaceuticals by 2015, IMS Health predicts.

Stepping up efforts to protect citizens from counterfeit products, the European Council (EC) is adopting the Falsified Medicines Directive aimed at preventing counterfeits from entering the supply chain.

The U.S. Food and Drug Administration (FDA) is collaborating with the World Health Organization (WHO) and other regulatory agencies around the world to improve regulatory science and advance global access to safe and effective vaccines and biologics.

A finalized collection of internationally recognized standards for study design may move to an open access, interactive platform, such as a wiki or Google document, to make updates as dynamic as possible.

Harmonized standards for clinical trial ethics should be applied globally, participants at a European Medicines Agency (EMA) workshop on clinical trials are urging.

The European Commission (EC) is following through on its threat to refer Spain to the EU’s Court of Justice (EUCOJ) after the member state reduced its rate of value added tax (VAT) for medical equipment.

The European pharmaceutical industry is calling for the EC to favor balanced pricing and reimbursement over cost control in its review of the EU Transparency Directive.

The European Medicines Agency (EMA) is defending its transparency initiatives as an article in the British Medical Journal (BMJ) calls for better access to unpublished documents.

EU member states may release pharmaceutical inspection outcomes in response to postmarket information requests, but specific details related to facilities and equipment are confidential, according to draft guidance from the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

As the number of studies conducted in Finland continues to drop, the government and industry are teaming up on initiatives to promote clinical trials in the country.

India’s Drugs Controller General has released new industry guidance to combat formatting inconsistences and speed up processing for reports of serious adverse events (SAEs) in clinical trials.

A new Brazilian law requires using protocols and guidelines as part of enhanced assessment processes to increase access to medicines through the country’s national health system, the Sistema Unico de Saude System (SUS).

Chile’s pharmaceutical industry could see a new drug regulatory agency under recent proposals to improve regulation, but an industry analyst argues the country is unlikely to make big changes anytime soon.

Australia’s Therapeutic Goods Administration (TGA) is updating its risk-management approach for medical products shortly after a report called on the agency to use a risk-based, streamlined approach in assessing safety and efficacy.

Australia’s Therapeutic Goods Administration (TGA) has published guidance to overseas drugmakers on the acceptable forms of good manufacturing practice (GMP) compliance evidence and how to submit the evidence to the TGA for assessment. Includes the full text of Australian GMP Guidance for Overseas Manufacturers.

A group of U.S. patients with Fabry disease intensified their campaign to get an open license for Genzyme’s Fabrazyme during an ongoing shortage, citing preferential treatment of Fabry patients in Europe.