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EMA Developments

The European Medicines Agency recently finalized a Guideline on the clinical investigation of medicinal products for the treatment of asthma. The guideline will be effective May 1, 2016. The current version of the guideline includes a section on the treatment of asthma in children, some considerations for the development of immunotherapy, and focuses on control-based management of the disease.

In a recent press briefing, EMA Executive Director Guido Rasi discussed his vision for the next five years. Dr. Rasi emphasized EMA’s commitment to transparency, patient involvement, and research and development for medicines that address public health needs. He also stressed the importance of strong cooperation between the member states, the European Commission, and other international partners.

ANSI Comments on Draft Chinese Standard

The American National Standards Institute (ANSI) publically released its comments on the on the draft Chinese national standard “Association Standardization—Part 1: Guidelines for Good Practice.” The ANSI comments recommend that Chinese associations be required to open participation in the standards development process to all stakeholders and encourages Chinese associations to practice transparency during the development process.

New Zealand Labeling Guidance

New Zealand has updated its labeling guidance to include MHRA guidance published in 2014 as a best practice document for guidance on labelling and packaging of medicines.

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CFDA Drug Reforms

The leader of the China Food and Drug Administration (CFDA), Bi Jingquan, has endorsed legislation reforming the drug approval process that would incentivize research and improve generic drug quality.

The CFDA has also issued guidance on the quality and efficacy of generic medicines for public feedback. According to RAPS, the draft document includes sections on the need for CFDA to retool its operation to oversee the consistent evaluation of generic filings and a call for a government-wide shift in approach to the sector.

CFDA also recently released text on how hospitals should test, maintain and calibrate medical devices, as well as on the importance on tracking device-related adverse events.

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