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China's hard‐to‐navigate drug approval system, slow processing, and unfavorable intellectual property protection environment have been major concerns for foreign Biopharma companies, but highly ranked central government officials have pledged to tackle these issues to encourage more advanced foreign drugs into the Chinese market and the Chinese health system. However, while China offers many opportunities, it still poses numerous challenges for biologic drug developers seeking to optimize biologics development and reduce product registration timelines. Global pharmaceutical companies are conducting more clinical trials in China as part of their international multicenter drug development programs.

Success in China depends on the regulatory know‐how in navigating the country's evolving drug regulatory landscape. Drug developers need to balance the great advantages of China's large (often chemo‐naive) patient population base and efficient study participant enrollment with obstacles posed by registration pathways for new and existing small molecule and biologic drugs.

The China Food and Drug Administration (CFDA), formerly the State Food and Drug Administration, considers drugs that are approved and marketed in other countries as new drugs in China. The CFDA designates previously approved therapies as category III “import drugs” and requires clinical data from trials conducted in China to support an application for an import drug license (IDL). This is currently the requirement for all drugs already marketed in another country.

However, for drugs that have not been approved in another international jurisdiction as yet, drug developers might choose to conduct a full clinical development program in China and submit a new drug application to gain market approval that may be achieved a several years earlier when compared with the category III pathway (China‐manufactured generic drug that is only approved outside China).

In China, multinational companies operate in a climate of rapid change and increasing harmonization with research standards and processes of mature drug markets. They also encounter some dramatic differences compared with the regulatory processes of the U.S. Food and Drug Administration (FDA), the EMA, and other major drug regulatory authorities. The CFDA has developed its own standards for good clinical practices (GCP), good laboratory practices (GLP), and good manufacturing practices (GMP). CFDA technical evaluation and administrative review takes from 7 to 12 months, compared to 30 days for the FDA's IND review and 60 days for an EMA CTA review.⁸