09 October 2018 132

ASEAN harmonization efforts to allow faster patient access to therapies

Harmonizing regulatory guidelines has a number of important advantages:

  • faster Marketing Authorization (MA) application approvals,
  • optimized internal workflows and processes that are easier to manage,
  • most importantly: improved time to market, giving patients faster access to therapies.

The International Conference on Harmonization (ICH) and the EU regulatory framework - managed by the European Medicines Agency (EMA) - are the two leading entities of proven harmonization efforts.

The Association of Southeast Asian Nations (ASEAN) is the Asian counterpart of both, using the ICH and EMA guidelines to harmonize their ASEAN guidelines. The Pharmaceutical Product Working Group (PPWG) - established in 1999 by the ASEAN Consultative Committee for Standards and Quality (ACCSQ) - has the objective to harmonize the pharmaceutical regulations of ASEAN member countries.

While in Europe MA can be obtained by submitting one MA application to EMA, the ASEAN countries still have diverse country-specific regulatory requirements that require country specific MA applications.

Differences between countries relate to, but are not limited to:

  • The use and validity of a Certificate of Pharmaceutical Product
  • The submission route of a registration application (online web-based submission, paper-based submission)
  • Pharmacopoeias acceptability
  • Halal compliance of the pharmaceutical product
  • Stability study setup
  • Product labeling requirements
  • Appointment of a Qualified Person (QP)
  • Dossier approval timelines

The ASEAN region is emerging in the pharmaceutical marketplace, but economic diversity, language, uneven distribution of wealth, intellectual property, and even with a lot of efforts taken there is a lack of harmonization of guidelines and their implementation.

This currently creates hurdles for pharmaceutical companies looking to penetrate these regions more effectively. Continuous efforts in harmonizing and implementing the ASEAN regulatory guidelines are crucial.

READ FULL ARTICLE (SOURCE: Regulatory Affairs Professionals Society).

How can we at CMAST help?

Having early visibility and information about country-specific and/or region-specific requirements and Health Authority expectations is key for pharmaceutical companies to improve MA application planning. Strategic planning is necessary for successful and timely product approvals. CMAST can aid in translating regulatory strategies into realistic deliverables and developing regulatory scenarios to support decision-making in line with your business strategy.

Leen Jacobs, Business Consultant

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