Regulatory Harmonization

 

The term “regulatory harmonization” can have different definitions depending on the context of its usage. One definition that is applicable to those efforts CBER is involved with is: the process by which the interpretation and/or application of technical guidelines can be made to be uniform or mutually compatible. The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER:

 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities and pharmaceutical industry experts from Europe, Japan and the United States to discuss scientific and technical aspects of product registration. ICH also includes the participation of Health Canada, the European Free Trade Association (represented by SwissMedic) and WHO as official Observers. CBER joins the Center for Drugs Evaluation and Research (CDER) as members to the ICH Steering Committee and provides technical representation to the various expert groups that undertake the work of ICH, i.e., Expert Working Groups, Implementation Working Groups, Informal Discussion Groups, Brainstorming Groups, etc.

 

Pharmaceutical Inspection Cooperation Scheme

In November 2010, FDA became a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), a network created in 1970 to promote cooperation in the field of GMPs among pharmaceutical inspectorates. The organization, which is based in Geneva, facilitates networking among its members (called Participating Authorities), exchanges inspectional information and experiences in the field of GMP and related areas, and trains GMP inspectors. There are currently 39 Participating Authorities in PIC/S which include most EU Member States, Switzerland, South Africa, Australia, Canada, Singapore and others. CBER has a representative on the FDA Steering Committee managing the Agency's interactions with PIC/S and actively participates in the technical group known as the PIC/S Expert Circle on Human Blood, Tissues and Cells. 

 

Asia-Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee

The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) is an on-going initiative founded on the idea that life sciences innovation is important in promoting public and economic health improvement. Early on APEC leaders recognized the importance of good regulatory performance in contributing to life sciences innovation and supported the LSIF’s role as an ‘enabler of regulatory harmonization’. APEC leaders promoted the use of existing international standards and best practices across a number of medical product lines and at the same time served as a vehicle to promote prospective harmonization dialogue in the area of advanced therapies. The LSIF supports a strategic, coordinated approach to harmonization activities, and strives to complement rather than duplicate the work of other parties, thereby leveraging respective resources and efforts. To that end, LSIF endorsed the establishment of the APEC Harmonization Center (AHC) as well as a Regulatory Harmonization Steering Committee (RHSC), both which were inaugurated in June 2009. CBER participates with other Agency components in the work of the RHSC.