News about GMP/cGMP


ICH: Meeting News from Lisbon

The International Council for Harmonisation (ICH) met in Lisbon, Portugal in June 2016. Two new members were accepted and 14 new observers welcomed.

Two pharmaceutical industry bodies were accepted as new Members:

  • The International Generics and Biosimilars Association (IGBA)
  • The World Self-Medication Industry (WSMI).



The list of Observers now includes:

  • Association of Southeast Asian Nations (ASEAN)
  • Biotechnology Innovation Organisation (BIO)
  • Central Drugs Standard Control Organization (CDSCO, India)
  • Council for International Organizations of Medical Sciences (CIOMS)
  • Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, Mexico)
  • East African Community (EAC)
  • European Directorate for the Quality of Medicines & HealthCare (EDQM)
  • Health Sciences Authority (HSA, Singapore)
  • International Pharmaceutical Excipient Council (IPEC)
  • Ministry of Food and Drug Safety (MFDS, South Korea)
  • Roszdravnadzor (Russia)
  • Food and Drug Administration (TFDA, Chinese Taipei)
  • Therapeutic Goods Administration (TGA, Australia)
  • United States Pharmacopeia (USP).

Two new topics for international harmonisation were endorsed by the Assembly:

  • The first is the development of a guideline on biopharmaceutical classification system-based biowaivers. The aim of the future ICH M9 Guideline is to achieve worldwide harmonisation of the applicability of biowaivers and the data needed to support such applications. The public health benefits include reducing unnecessary clinical trials, and facilitating the production and availability of good quality medicines especially in low and middle-income countries.
  • The second new topic is related to bioanalytical method validation, for which recent regulatory requirements have been introduced in EU, Japan and USA. The proposed ICH M10 Guideline will address the discrepancies between these provisions and those from other ICH regulatory members. A harmonisation approach will promote rational and effective studies and facilitate global drug development, thereby advancing the mission of ICH.

The next ICH meetings will be held on 5-10 November 2016 in Osaka, Japan, and in Spring 2017 in Montreal, Canada, to be hosted by Health Canada for the first time.


ICH Press Release



No comment has yet been written about this news

Write your comment about this news