Thoughts and Countermeasures on Strengthening the Foundation and Consolidating the Base of the Hospital Pharmaceutical Industry in the Post-Regulatory Era

OBJECTIVE To suggest for the high-quality development of the hospital preparation industry during the "15th Five-Year Plan" period, by focusing on the regulatory direction and key concerns of hospital preparations in the new era, and based on the current regulatory situation.

METHODS By using the phrase search method to review and sort out the policy documents, proposal suggestions and replyed letters during the "14th Five-Year Plan" period as well as the currently effective core regulatory documents on hospital preparations publicly released by the official websites of national institutions, summarized the current regulatory situation and put forward reference suggestions for the development of the hospital preparation industry.

RESULTS The regulatory policies and public concerns regarding hospital preparations in the new era mainly covered areas such as review and approval, dispensing and usage, new drug research and development, technology transfer, inheritance and development of ethnic medicines, and platform construction; the core regulatory provisions for hospital preparations currently in place mainly cover areas such as review and approval, payment methods, dispensing and use, and manufacture of preparations; however, some of the regulatory documents were outdated.

CONCLUSION It is necessary to recognize the significant value of hospital preparations in meeting clinical needs and promoting industrialization, strengthen its weak foundation from aspects such as new drug research and development and technology transfer, risk monitoring, and medication for children and other special groups, promote the scientific, standardized and characteristic development of its industry.