As segments of the global pharmaceutical market continue to cross and converge across national and regional borders, manufacturers of APIs, raw materials, and finished drug products throughout the world find themselves needing to comply with differing regulatory demands. Manufacturers have to balance requirements set forth by the more codified regulatory environments of the US and Europe while contending with the rapidly transforming nature of other healthcare markets such as China or India. Differences in regulatory systems are based on several factors, including healthcare priorities as well as specifications for product quality that differ from country to country. These regulatory complexities can create additional challenges for the manufacturer in attaining the ultimate goal of providing good quality medicines to patients worldwide.
V. Srini Srinivasan
A nonprofit scientific organization, the US Pharmacopeial Convention (USP) establishes standards in various compendia for the identity, strength, quality, and purity of medicines and their ingredients. Under US federal law, standards published in the United States Pharmacopeia and the National Formulary (USP–NF) are enforceable by FDA for products manufactured or marketed within or imported to the US. As systems for global pharmaceutical manufacturing, distribution and regulation increase in complexity and as FDA increases its inspections of manufacturing sites outside of the US, USP's standards-setting activities are becoming increasingly focused on relationships built with partners worldwide.
Communicating through scientific exchange
On Sept. 18-19, 2013, USP and the Chinese Pharmacopoeial Commission (ChP) will cohost the 10th Annual USP Science and Standards Symposium in Baltimore, Maryland, in partnership with the Drug Information Association (DIA). The symposium will be the sixth in a series of annual joint meetings cohosted by USP and ChP. With the theme "Partnering Globally for 21st Century Medicines," the symposium will focus on regulatory and compendial topics relevant to the manufacture of chemical and biological medicines, herbal medicines, and excipients.
During the course of the past decade, USP has made great progress in strengthening its ties with ministerial and regulatory bodies responsible for the regulation of medicines in China, India, Brazil, and other parts of the world. A key driver for building these relationships has been the ongoing exchange of information and knowledge on public standards for medicines, dietary supplements, and food that undergird the regulatory framework for each country.
Setting the stage for the two-day symposium will be keynote presentations by thought leaders invited from the China Food and Drug Administration (CFDA), the National Institutes of Health, FDA, and global pharmaceutical manufacturers. Speakers will share insights on the role that modern medicines play in healthcare systems and healthcare delivery in both China and the US. Mechanisms to promote the availability of good-quality modern medicines and that help ensure patient and consumer access will be addressed with a focus on both challenges and opportunities. Invited speakers include Wang Lifeng, director general of drug registration at CFDA; Roger Williams, PhD, chief executive officer of USP; Wang Ping, deputy director general of ChP, and representatives from FDA.
On day one of the symposium, general sessions will highlight industrial, regulatory, and pharmacopeial perspectives on the manufacturing areas aforementioned. The second day will offer presentations by experts from industry, USP, and ChP on subjects such as:
- Monograph and reference standard development practices—perspectives from ChP and USP
- Elemental and organic impurities control in the USP–NF as well as the Chinese Pharmacopoeia
- Assay transitions in biological medicines
- Defining excipient quality and reporting on modernization and harmonization of excipient standards
- Advances in and international perspectives on traditional medicines
- Legacy biologic products and naturally derived materials—raising the analytical bar.
Immediately following the symposium, USP will host the Global Summit of the Pharmacopoeias. This event will convene representatives of pharmacopoeias invited from multiple countries such as India, Brazil, China, Vietnam, and others and provide a forum for exchange about areas of shared interest and potential collaborations. Registration information and a symposium agenda can be found at http://uspgo.to/S3-Baltimore.