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.
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.
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.
In October 2015, FDA issued a combination product review assessment recommending several improvements to current processes. Recommendations include new guidance to clarify the review process. The report contains an endorsement of the study by Dr. Robert Calliff, FDA Commissioner nominee.
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.
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.
Two US Senators have introduced a bill entitled, “The Combination Product Regulatory Fairness Act of 2015.” The bill is intended to streamline device / drug combination registrations at FDA by letting the agency rely on prior PMAs and approved drug findings to help support new product approvals.
The Australian Minister for Health and Parliamentary Secretary to the Prime Minister have released a “Review of Medicines and Medical Devices: Stage One Report” with 32 recommendations on the regulatory framework. The second report will cover the regulatory framework for complementary medicines and the advertising of therapeutic goods.
India’s regulatory authority has announced that they will open to international regulators a database of track and trace information for drugs exported from India. The database is currently in a pilot phase with certain drug exporters uploading data.
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.
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”.
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.
India has released a National Medical Device Policy document proposing the establishment of a National Medical Device Authority (NMDA) within the Department of Pharmaceuticals. The policy also details plans for a separate pricing division to set medical device price controls. Comments on the draft policy are requested within six weeks.
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.
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.”
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.