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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.

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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.

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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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FDA 2016 Regulatory Science Priorities for Generic Drugs

FDA recently published a list of 2016 regulatory science priorities for generic drugs, including post-market evaluation of generic drugs; equivalence of complex products; equivalence of locally-acting products; therapeutic equivalence evolution and standards; and computational and analytical tools. The FDA OGD Research Priorities for 2016 include equivalence of inhalation and nasal products, nanomedicines, and IVIVC dissolution methods.

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Russian Drug Import Updates

Russia has passed an amendment to federal drug law stipulating that local authorities must consult federal regulators to set the price of drugs on the list of essential medicines. The amended federal law also clarifies the reference medicinal product, procedures for handling drugs and for registration, accelerated approval process, and situations in which clinical trials may be suspended.

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EMA Pediatric Initiative

The European Medicines Agency has started a one-year pilot for free early interaction meetings with pharmaceutical companies on pediatric medicinal development. The aim of this pilot program is to advance discussions on how a specific medicine can address pediatric needs before the submission of a pediatric investigation plan.

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Proposed Canadian Drug Shortage Rules

Canada has issued draft regulations requiring the reporting of drug shortages and discontinuations. This regulation would require online notices to be posted six months in advance of anticipated shortages or discontinuations, and within two days of unexpected shortages. It would also apply to a wide range of drugs, not only those labeled “medically necessary”.

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FDA Request for Comment

FDA has issued a notice requesting public comments on whether the use of CFCs or other ozone-depleting substances in FDA-regulated products are now considered essential under the Clean Air Act, given the availability of alternative products that do not use CFCs. Essential products are exempt from the FDA and EPA ban on CFC propellants and use in pressured dispensers.

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EMA Labeling Changes

The European Medicines Agency has updated product information templates to ensure that product leaflets include more specific information on marketing-authorization holders in each EU member state and to allow all strengths of a pharmaceutical form to be combined in one entry.

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FDA Proposes Rule on Fixed-Dose Combination Drugs

The US Food and Drug Administration announced plans for a new proposed rule on Fixed-Dose Combination Products that would also cover co-packaged drug and/or biological products. According to the FDA, “the proposed rule would create a single set of regulations for prescription and OTC combination drugs, and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met.”

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Australian Orphan Drug Program

Australia’s Therapeutic Goods Administration recently released a discussion paper on their orphan drugs program. The paper is intended to review whether the orphan drug program is fulfilling its intended purpose and to review the financial implications of the program.

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