Industry Trends: WHO Five-Year Plan, MRA Implementation, and Generic Drugs in China

welocalize July 17, 2019

In case you missed these developments across the life sciences industry, here is a quick insight into some of the latest trends and news, from generic drug development in China to new guidance on device vigilance system.

WHO Lays Out Five-Year Regulatory Action Plan

According to Regulatory Focus, the World Health Organization (WHO) crafted a five-year plan to promote regulatory collaboration and reliance, and to help national regulatory authorities (NRAs) solve capacity issues and other challenges. This plan prioritizes regulatory initiatives to help WHO Member States increase access to universal health coverage (UHC), support health emergency responses, and promote healthier populations. Access WHO’s five-year plan to help build effective and efficient regulatory systems.

Why should the industry take note of this development? According to WHO, only 30% of national regulatory authorities have the capacity to effectively and efficiently regulate medical products. The five-year plan aims to increase collaboration and strengthen regulatory systems for low and middle-income countries.

Photo by L. Cipriani for WHO: Delegates at the World Health Assembly gathering for the opening of the first plenary meeting

China Looks to Boost Generic Drug Development

China’s National Health Commission published its first proposed list of 34 drugs that the agency says are already off patent or nearing patent expiration but have no generic drug application in the country or lack competition. According to FiercePharma Asia, “The plan is to invite drugmakers to make copies under drug regulator’s priority review pathway, which was until now mostly given to innovative drugs.”

Why should the industry take note of this development? With some high-demand drugs losing patent protection and fewer drugs entering the market than before, pharmaceutical companies are racing to obtain patent protection in order to recoup their research and development expenditure. Welocalize Life Sciences helps pharma, biotech, and device manufacturers prepare drug and device patents for international markets.

According to Regulatory Focus, while highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the EC issued guidance on the medical device vigilance system under the EU’s medical device directive. The MIR introduces the use of harmonized adverse event terminology/coding. Other clarifications in the new EC guidance relates field safety corrective actions and the role of a vigilance taskforce. See more about the additional guidance regarding the vigilance system.

Why should the industry take note of this development? MDR 2020 is just around the corner. Welocalize Life Sciences shares the ins and outs of the new regulation, as well as how we can help medical device manufacturers with translation of labels, CE Markings, and IFUs.

MRA for Inspections of Manufacturing Sites Fully Implemented

EU national authorities and the FDA inspect many production sites of medicinal products in the EU, the US, and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). The EMA recently announced that the EU and the US have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. Under the MRA, EU and US regulators will now rely on each other’s inspections for human medicines in their own territories and avoid duplicative work. Read more.

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