China's FDA Becomes a Member of ICH

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-29-2017 18:41


Among the decisions made at its most recent meeting held May 27 to June 1, 2017 in Montreal, Canada, the International Council for Harmonization (ICH), an organization bringing together regulatory bodies, approved the China Food and Drug Administration (CFDA) as a new regulatory member and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new observer. With these new parties, there are now 14 members and 23 observers in the ICH.

The ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved to respond to the increasingly global face of drug development by greater harmonization through the development of ICH guidelines via a process of scientific consensus with regulatory and industry experts and a commitment of ICH regulators to implement final guidelines developed by the ICH.

The CFDA is the national regulatory authority in China. PIC/S is a non-binding, informal cooperative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use. PIC/S is currently composed of 49 participating authorities from around the world (Europe, Africa, America, Asia, and Australasia).

Also at its new meeting, the ICH Assembly agreed to begin work on two new topics. The first is for a new international harmonized guideline on extrapolation for pediatric medicines. The new Working Group will further advance the use of pediatric extrapolation, which is the focus of the new ICH E11(R1) guideline currently under development. The aim is to provide guidance on incorporating extrapolation methods in an overall approach to pediatric medicinal product development. ICH says that a harmonized approach to the appropriate use of extrapolation from adult data will improve the speed of access to new drugs for children.

The second new topic is the revision of the 1997 ICH E8 guideline on general considerations for clinical trials. This is part of the strategic "Good Clinical Practice renovation" announced at ICH's meeting in November 2016 in Osaka, Japan. The revision will look at study design, planning, and conduct with a focus on identifying and supporting a basic set of critical-to-quality factors. ICH says that improved clinical trials contribute to public health by generating better evidence to inform regulatory decision-making, avoiding the need for repeat trials and unnecessary exposure for trial participants, and helping to avoid discontinuation of promising development programs.

ICH also announced the finalization of several guidelines. The final M7(R1) addendum to the guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk was adopted by the ICH Assembly at Step 4 of the ICH process, Step 4 is reached when the Assembly agrees that there is sufficient consensus on a draft guideline, and the guidelines are put forth for adoption by ICH regulatory members. The addendum provides a list of compounds for which mutagenic potential and the threshold of toxicological concern have been established.

The ICH Assembly also adopted at Step 4 the update of the Questions and Answers on the implementation guide package of the guideline, E2B(R3): Electronic Transmission of Individual Case Safety Reports.

The ICH also announced some operational changes. With a view to streamlining the operation of ICH, the ICH Assembly made some revisions to the articles of association and rules of procedure. With a growing number of members and observers, the changes include caps on the size of Expert Working Groups to ensure they remain a manageable size and revisions to the criteria for an international organization to become an observer. .

The Assembly also welcomed the plan of the International Federation of Pharmaceutical Manufacturers & Associations, a global health organization for research-based innovator pharmaceutical companies and a standing observer to ICH, to initially use its seat on ICH Working Groups to facilitate the participation of IFPMA National Association experts in Working Groups.

The next ICH meeting will take place November 11-16, 2017 in Geneva, Switzerland.

Source: ICH


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