Global outreach
While inspections and import alerts attract public attention, FDA also emphasizes its role in China and other regions in educating public officials and industry leaders on US policies and standards. Sklamberg’s GO organizes a range of capacity building programs and collaborative activities designed to strengthen regulatory systems in developing countries and to explain US and international manufacturing policies and standards to local authorities.
Similarly, leading trade and professional organizations are broadening international outreach and educational programs to support these efforts. The Parenteral Drug Association (PDA) has a European subsidiary and chapters around the world, including a new one in Singapore. These entities hold conferences and training courses on quality manufacturing and testing, as seen in a program this month on parenteral manufacturing in Istanbul.
The Drug Information Association (DIA) recently established its global headquarters in Washington, D.C. to better serve 18,000 members in 80 countries through operations in Europe, Japan, India, China, and Latin America. DIA’s chief executive, Barbara Lopez Kunz, came from Battelle with strong international management experience to oversee DIA’s worldwide growth, which will be highlighted at its 50th annual meeting this month.
The International Society of Pharmaceutical Engineers (ISPE) is unveiling a Drug Shortages Prevention Plan this month, along with plans to collaborate on a similar proposal for the EMA. ISPE and PDA are working with European associations and regulators to craft a plan that addresses shortage-related quality issues relevant to the European market.
Global expansion has been a prominent theme at the United States Pharmacopeia (USP), which now has offices and laboratories in India, China, and Brazil to provide local manufacturers with access to reference standards, test methods, and training programs on correct procedures for testing and ensuring product quality. USP’s Promoting the Quality of Medicines initiative, which is funded by the US Agency for International Development, also assists manufacturers in developing nations produce medicines that meet quality and safety standards; a recent five-year extension of the program will provide up to $75 million for USP to provide technical assistance to government regulatory systems in establishing domestic quality control laboratories, quality monitoring systems, and effective domestic regulatory authorities.
Efforts to harmonize pharmacopeial standards in different regions over several decades have been stymied by differences in legal authority and traditional practices in different countries. Pharmacopeial harmonization now is shifting to a more prospective approach, working with the World Health Organization to develop common testing practices and standards-setting processes.
These activities will be on the agenda at the next USP convention in April 2015, which will set the stage for USP programs through 2020, when the organization marks its 200th anniversary. To prepare for these and other challenges, USP’s new chief executive officer, Ron Piervincenzi, is consulting with stakeholders, reviewing the organization’s operations, and examining options for future growth and change.
About the Author
Jill Wechsler is BioPharm International's Washington editor