PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced that the Company has launched a new China Advisory Service to help global biopharmaceutical companies participate in the growing, yet complex market opportunity within China.
The offering leverages PAREXEL’s deep experience with and knowledge of the Chinese biopharmaceutical landscape to help companies navigate all aspects of the country’s drug development process.
This includes overall strategy, agency engagement and agreements, early development, clinical operations, and regulatory, market access, and commercial strategies.
China’s regulator, the National Medicinal Products Administration (NMPA, formerly CFDA), has undergone significant reform in recent years, including the introduction of expedited approval pathways, acceptance of data from Multiregional Clinical Trials (MCRTs) to support marketing applications, first-in-human studies and Clinical Trial Approvals (CTAs) in 60 days.
While these reforms have made the regulatory environment in China more accessible to global pharmaceutical companies, significant barriers to entry remain.
These barriers include government-mandated price controls in public medical insurance programs, complex price negotiation processes at national and provincial levels, complex distribution channels, infrequently updated formularies, and an absence of GMP-compliant manufacturing testing sites and GCP-compliant clinical sites.
The Chinese government is committed to becoming a major player in the global pharmaceutical industry and in recent years significant changes have been made with the goal of assessing novel therapies for its population and bringing China to the forefront of drug development."
Chang Lee, M.D., MSHA, DrPH, Vice President of Consulting for PAREXEL in China.
Chang continued, “These changes have come very quickly and have resulted in an extremely dynamic landscape for companies looking to enter the market. The ability to quickly understand and adapt to these changes is critical to succeeding in this rapidly-changing environment.”
The China Advisory Service aims to guide global biopharmaceutical companies as they evaluate the market opportunity in China, become a Marketing Authorization Holder (MAH), ensure compliance with NMPA, attain favorable formulary status and pricing, and commercialize safe and compliant drugs in the market.
Leveraging PAREXEL’s operational experience in conducting phase I-IV clinical research in China, the Company’s dedicated team based in China includes several ex-NMPA personnel and global regulatory leaders, as well as dedicated regulatory consultants and market access experts.
PAREXEL teams have also been part of the process to shape local policies, including working with the NMPA to support guideline development and Center for Drug Evaluation (CDE) education programs, and participating in new policy discussions, research project and CDE meetings.
“In just a short time, China has grown from being an emerging market for companies looking to develop drugs to the second largest biopharmaceutical market in the world. While many are aware of the opportunity that exists in the market, the challenges and hurdles to entry are generally not well understood,” said Paul Bridges, Corporate Vice President and Worldwide Head of Consulting, PAREXEL.
PAREXEL has significant first-hand experience working in China and with local regulators, and with this offering we aim to partner with our clients as they consider and navigate this exciting yet complex market opportunity”