International Pharmaceutical Regulatory Monitor

CHICAGO— The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have set up a new cluster on biosimilar medicines, and that could help the FDA catch up in its development of an abbreviated pathway to approve the generic biologics.

The European Council’s proposed reforms to the judicial system for the EU-wide single patent system will exclude third-party countries, according to a “non-paper” on the topic.

The European Commission (EC) is pushing for development of harmonized safety features and tighter controls for pharmaceuticals under a new directive intended to block falsified medicines from entering the supply chain.

Marking its first step to implement recent pharmacovigilance legislation, the European Medicines Agency (EMA) has published formatting requirements for manufacturers to use when they submit authorized or registered medicines in the EU.

To harmonize and facilitate the exchange of clinical trial information and assessments, the European Union is working toward a one-submission application for trial approval.

The European Medicines Agency (EMA) is considering three new regulatory initiatives to improve drug safety and access, including adaptive licensing — authorizing drugs sooner but with greater initial limitations.

A new memorandum of understanding (MoU) between the U.S. Critical Path Institute (C-Path) and the EU’s Innovative Medicines Initiative (IMI) may help accelerate drug development by driving agreements on testing methods.

U.S. and European pharma companies “are misinformed about the identity of manufacturers involved in all or part of the supply chain of 39 percent of drug substances they purchase from China,” an industry expert says.

The UK pharmaceutical industry is raising concerns over the country’s General Medical Council (GMC) proposed guidance on prescribing off-label or unlicensed medicines.

Biopharmaceutical manufacturers may see the Czech Republic as a promising market, thanks to increased cooperation between industry and regulators.

Drug manufacturers in New Zealand (NZ) and Australia will see reduced barriers to market thanks to an agreement between the two nations to implement a joint regulatory agency within the next five years.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is implementing several initiatives to improve consultations with industry as part of the overall goal to quicken drug application reviews.

While compulsory licensing in India is sometimes advocated as the best way to bring innovative medicines to poor patients, industry representatives see technology transfer and patent linkages as potentially better options.

Drug manufacturers working in India should take into account a new code of marketing practice to follow in the country, which bans bribery and regulates promotional materials.

Brazil’s National Health Surveillance Agency (Anvisa) and Sweden’s Läkemedelsverket (Medical Products Agency) have signed a cooperation agreement to share information and discuss mutual areas of interest.

Russia is striving to become a larger part of the global pharma industry through transparent partnerships that provide products to local and global markets, according to industry and government representatives.

Clinical trials in Russia during the first quarter of this year decreased by 29 percent compared to the same time period last year, according to a new report.

The U.S. Food and Drug Administration (FDA) is implementing a new strategy to handle rising imports and an increasingly complex global supply chain, and it plans to begin partnering with its foreign counterparts over the next year, an agency report says.