Regulatory Focus™ > News Articles > ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting

ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting

Posted 01 July 2016 | By Zachary Brennan 

ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting

The recently renamed International Council for Harmonisation (ICH) is adding new pharmaceutical and medical device regulators, industry groups and the US Pharmacopeia (USP) into its ranks as observers.

The push to increase membership is part of the council’s global expansion.

Announced at ICH’s June meeting in Lisbon, the new observers, who follow the addition of five regulatory authorities and regional health initiatives in December 2015, include:

  • 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)
  • Taiwan’s Food and Drug Administration (TFDA, Chinese Taipei)
  • Therapeutic Goods Administration (TGA, Australia)
  • USP 

Lisbon Meeting

According to a statement on the meeting, highlights included the adoption of a final revised guideline on the format and structure of benefit-risk information in the common technical document (ICH M4E (R2)), which will now be implemented by each regulatory member.

"Given the importance of benefit-risk assessment for drug regulation, this is expected to support regulatory decision-making through a more consistent description of information coming from clinical trial data, as well as other factors such as disease severity and availability of other treatment options," ICH said.

"Recognising the increasing role of the patient voice in drug development and regulation, the revised guideline also opens the possibility to include information about patient perspectives, for example information from patient preference studies."

The council also endorsed a draft guideline to support the planning and design of multi-regional clinical trials and to reduce any unnecessary duplication of trials (ICH E17). The draft guideline will now be released for stakeholder consultation, with adoption of the final guideline planned for 2017.

Formal adoption of ICH E6 (R2) is also expected later in 2016, with an addendum "designed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality."

ICH also endorsed a draft Q&A document aimed at clarifying a 2009 ICH guideline on the non-clinical evaluation of anticancer products (ICH S9 Q&A) that will now be released for stakeholder consultation and are intended to clarify the scope and implementation of the guideline, and support the development and evaluation of medicines for faster access for patients with serious and life-threatening cancers.

Two new topics for international harmonisation were endorsed by the ICH Assembly, including the development of a guideline on biopharmaceutical classification system-based biowaivers and bioanalytical method validation, for which recent regulatory requirements have been introduced in the EU, Japan and US.

The aim of the future ICH M9 Guideline is to achieve worldwide harmonization of the applicability of biowaivers and the data needed to support them.

"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," ICH said.

And the proposed ICH M10 Guideline will address the discrepancies between the recent regulatory requirements on bioanalytical method valuation and those from other ICH regulatory members.

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.

The groups and regulators comprising ICH now include:

Founding Regulatory Members

  • The European Commission (EC)
  • The US Food and Drug Administration (FDA)
  • The Ministry of Health, Labour and Welfare of Japan (MHLW), also represented by the Pharmaceuticals and Medical Devices Agency (PMDA)

Founding Industry Members

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • The Japan Pharmaceutical Manufacturers Association (JPMA)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)

Standing Regulatory Members

Industry Members

  • The International Generic and Biosimilar Medicines Association (IGBA)
  • The World Self-Medication Industry (WSMI)

Standing Observers

  • International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  • World Health Organization (WHO)

Observers

Legislative or Administrative Authorities

  • Agência Nacional de Vigilância Sanitária (ANVISA, Brazil)
  • Central Drugs Standard Control Organization (CDSCO, India)
  • The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, Mexico)
  • The Health Sciences Authority (HSA, Singapore)
  • The Ministry of Food and Drug Safety (MFDS, South Korea)
  • Roszdravnadzor (Russia)
  • Taiwan’s Food and Drug Administration (TFDA, Chinese Taipei)
  • The Therapeutic Goods Administration (TGA, Australia)

Regional Harmonisation Initiatives (RHIs)

  • Asia-Pacific Economic Cooperation (APEC)
  • Association of Southeast Asian Nations (ASEAN)
  • East African Community (EAC)
  • Gulf Cooperation Council (GCC)
  • Pan American Network for Drug Regulatory Harmonization (PANDRH)
  • The Southern African Development Community (SADC)

International pharmaceutical industry organizations

  • Biotechnology Innovation Organization (BIO)

International organisations with an interest in pharmaceuticals

  • The Council for International Organizations of Medical Sciences (CIOMS)
  • The European Directorate for the Quality of Medicines & HealthCare (EDQM)
  • The International Pharmaceutical Excipient Council (IPEC)
  • The United States Pharmacopeia (USP)

ASSEMBLY AGENDA PAPERS 15 – 16 June 2016 Lisbon, Portugal

ICH increases its global reach, moves forward on global drug development

 


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