ICH Discusses Global Drug Development and Biopharma Guidelines

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ICH detailed the highlights of the council’s June 2016 meeting.

The International Council for Harmonization (ICH) plans for new harmonization of biopharmaceutical classification system-based biowaivers and bioanalytical method validation as well as continued harmonization of global drug development and benefit-risk assessment. The council announced these plans after a meeting held on June 11–16, 2016 in Lisbon, Portugal.

The assembly endorsed international harmonization of a guideline on biopharmaceutical classification system-based biowaivers, ICH M9. The goal of the guideline is to “achieve worldwide harmonization of the applicability of biowaivers and the data needed to support such applications.” ICH hopes the guideline will reduce unnecessary clinical trials and improve the availability of quality medications in low and middle-income countries.

Also proposed is ICH M10, which will harmonize regulatory requirements for bioanalytical method validation. According to ICH, the European Union, Japan, and the United States have already introduced their own guidelines, and “a harmonization approach will promote rational and effective studies and facilitate global drug development, thereby advancing the mission of ICH.”

The council reaffirmed its commitment to ongoing harmonization efforts. ICH adopted a final revised guideline on format and structure of benefit-risk information in the common technical document (ICH M4E [R2]). In regards to global development, the council endorsed ICH E17, which supports the planning and design of multi-regional clinical trials. The addendum to ICH E6, which offers guidance on good clinical practices, is expected to be adopted in late 2016. And a draft question and answers document to ICH S9, the council’s guideline on non-clinical evaluation of anticancer products, is being released for stakeholder consultation.


ICH also announced the addition of two new members, the International Generics and Biosimilars Association (IGBA) and the World Self-Medication Industry (WSMI), and 14 new Observers, which included the Biotechnology Innovation Organization (BIO), the United States Pharmacopeia (USP), the European Directorate for the Quality of Medicines & Healthcare (EDQM), International Pharmaceutical Excipient Council (IPEC), and other regulatory agencies.

Source: ICH