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Feb 1, 2018

Update: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance for Industry and Food and Drug Administration Staff

The PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process.

Focusing the Agency’s review resources on complete applications will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. Moreover, with the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device User Fee Amendments of 20171 FDA agreed to performance goals based on the timeliness of reviews. Acceptance review therefore takes on additional importance in both encouraging quality applications from PMA applicants and allowing the Agency to appropriately concentrate resources on complete applications.

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Best Practices for Communication Between IND Sponsors and USFDA During Drug Development
Guidance for Industry and Review Staff

The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). This guidance describes:

  • FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between review teams and IND sponsors
  • The types of advice appropriate for IND sponsors to seek from FDA in pursuing their drug development programs
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between review teams and IND sponsors during drug development
  • Expectations for appropriate methods, including the frequency, of such communications

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EMA surveys pharma companies on their preparedness for Brexit
Planning of regulatory steps needed to ensure medicines remain on EU market

The European Medicines Agency (EMA) is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the United Kingdom (UK), or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance(QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the UK’s withdrawal from the European Union (EU).

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CFDA applying ICH technical guidelines to drug filings, safety management
CFDA’s follow up on full ICH membership

Having become a full member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in June last year, the CFDA is quickly moving to apply various ICH guidelines to serve as the basis for drug reviews and approvals. As part of reforms designed to accelerate the handling of innovative drugs, five of the ICH’s Tier 2 guidelines will be adopted in stages. From February 1, 2018, the ICH M4 “Common Technical Document” for the registration of pharmaceutical products will be applied to all chemical drug Category 1 and 5.1, and both therapeutic and preventive biologics category 1 filings.

The CFDA will also require that clinical trial safety data and reports are carried out according to ICH standards from May 1 this year, while the Council’s standards for post-marketing adverse events reporting will be applied from July 1, 2018. In a separate announcement, the CFDA released technical guidelines for filings related to innovative drugs at the Phase I clinical trial stage, as the agency pushes on with plans to raise drug regulation up to international standards and drive the development of an innovative local industry. To achieve these goals, the CFDA has released a blizzard of reform policies over the last 2 years.

Source: GBI (")

CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards

The China Food and Drug Administration (CFDA) is preparing to raise the levels of information disclosure and transparency surrounding drug reviews and approvals. Last week, draft proposals were released seeking public feedback on exactly how information will be disclosed by the Center for Drug Evaluation (CDE) in future.

The proposed measures include requiring the CDE to publish its decisions and reasoning for priority reviews and special approvals. If implemented, the CDE would also be obliged to produce technical review information for all novel drugs and generics within 60 working days of market approval. For generics that have passed quality and efficacy consistency evaluation, details of product specifications, corporate reports, and bioequivalence test data among others will also be released, as well as being listed in the recently released “Listed Drugs Catalogue of China”. The proposals for greater transparency follow the CFDA’s formal admission to full membership of the ICH – the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – in June last year, part of efforts to upgrade China’s drug review and approval system in line with international norms.

Source: GBI (

CFDA’s “Orange Book” launch marks new era of quality generics
Standards for generic products will ensure quality throughout the Chinese market

The China Food and Drug Administration (CFDA) marked the turn of the year with the formal release of a first iteration of the "Listed Drugs Catalogue of China”, in other words a Chinese version of the U.S. FDA’s “Orange Book”. The Catalogue is expected to provide a full record of all newly listed drugs, including details such as API, dosage form, specification, marketing license holders, and patent information, alongside details of all generic drug products that have been approved as matching the original in terms of quality and bioequivalence. The CFDA is starting slowly, the first iteration including 131 drug varieties and 203 individual drug specifications. The list includes 13 generic drugs in 17 specifications that have met China’s recently introduced quality and efficacy equivalency standards compared with originator reference products. A total of 39 multinational pharmaceutical companies have products on the list, Pfizer leading with 28 drug listings.

The Chinese version of the Orange Book is a key part of the CFDA’s overarching drug approval system reforms, and will support the development of a patent linkage system. Directly modelled on the U.S. example, the aim is to establish Hatch-Waxman-style underpinnings that will both encourage innovative drug development while rewarding generic manufacturers producing high-quality products. The plans for patent linkage and a Chinese Orange Book were first broached in the CFDA’s Circular No. 55, released in May 2017.

Source: GBI (


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