Another positive development is efforts by regulatory authorities in Latin America, Asia, and Africa to develop regional standards
and cooperative arrangements that reflect local needs and capacities. A clear goal is to attract more pharmaceutical production
and investment to spur economic development programs. Regulatory capacity building is a top priority, and benefits from FDA
providing technical expertise through the agency's Forum for International Drug Authorities.
The Pan American Network for Drug Regulatory Harmonization (PANDRH) was established in 2000 by the Pan American Health Organization
(PAHO) to promote technical agreements on drug regulation and to build regulatory capacity at national agencies, with the
aim of encouraging convergence in drug regulation, explained PAHO senior advisor James Fitzgerald. More experienced regulatory
authorities in Argentina, Brazil, Colombia, Cuba, and Mexico have begun to share GMP inspection reports, information on product
recalls, and inspection schedules to strengthen oversight activities. A PANDRH GMP working group is developing a harmonized
questionnaire for inspections to verify compliance with manufacturing standards based on World Health Organization (WHO) standards;
a goal is to provide GMP certificates to firms based on inspections by one of the advanced authorities.
African officials similarly are looking to spur pharmaceutical production in the region to ensure a sustainable supply of
quality essential medicines and promote industrial development. The over-arching strategy is to shift drug oversight from
54 divergent national regulatory authorities to 5 to 7 regional economic communities with harmonized policies and laws that
permit fewer dossiers and clear timelines for drug registration, explained Margareth Ndomondo-Sigonda of the African Union's
New Partnership for Africa's Development. Under the Medicines Registration Harmonization Project of the East African Community
(EAC), for example, health and regulatory officials are developing guidelines on label formats, patient information leaflets,
stability requirements, and registration forms. A GMP technical working group is finalizing a GMP inspection manual, standard
operating procedures for conducting GMP inspections, and formats for writing GMP summaries and reports.
Mike Ward, manager of international programs at Health Canada, outlined efforts by the Asia-Pacific Economic Cooperation (APEC)
organization to promote technical cooperation through its Life Sciences Innovation Forum. A Regulatory Harmonization Steering
Committee was formed in 2008 to promote medical product innovation, followed by the APEC Harmonization Center, which provides
resources for APEC to serve as a catalyst for regulatory convergence and capacity building. One priority work area is to describe
best practices for ensuring supply-chain integrity, while others are examining good review practices, pharmacovigilance, and
Vaccine development and oversight provides a prime area to test harmonization approaches. The African Vaccine Regulatory Forum
(AVAREF) brings together regulators and ethics committees to examine and jointly review applications from vaccine manufacturers
seeking to conduct clinical trials in the region. Such a process not only promotes convergence, but also can build "mutual
trust" between neighboring countries as participants can see the quality of inputs from their peers, noted David Wood, WHO
coordinator of quality, safety, and standards for vaccines and biologicals.
One danger is that collective efforts to establish common regulatory approaches among national authorities will lead to policies
and standards that differ between key regions. To achieve simultaneous global drug development and near-simultaneous registration
around the world, said Honig, all parties have to agree on expectations for clinical-trial operations, pharmacovigilance processes,
and data transparency. The role of regulators, said Douglas Throckmorton, deputy director, Center for Drug Evaluation and
Research, is to provide clarity on rules and regulations and to ensure a level playing field between domestic and foreign
manufacturers. Harmonization requires regulators to "give up some control" over their policies and programs, observed Deborah
Autor, FDA deputy commissioner for global regulatory operations and policy. She urged workshop participants to further articulate
the business case for global regulatory convergence, spelling out the gains and efficiencies it can provide, and a plan for
addressing key gaps to get global coalitions moving. Steven Galson, vice-president for global regulatory affairs at Amgen
and co-chair of the workshop, said the next step is for industry and regulators to craft an economic analysis documenting
the enormous savings in resources from harmonization. The parties represented at the gathering, he commented, have the power,
force, and creativity to "go forth and converge" and should do so without delay.
1. IOM, International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development, Workshop
(February 13-14, 2013).
Jill Wechsler is Pharmaceutical Technology's Washington editor, tel. 301.656.4634, firstname.lastname@example.org