We conducted a research on China's bioproducts and biomedicine evaluation policy this year.
Firstly, we did a literature review about the policy, regulation,
and laws regarding the interaction of biopharmaceutical industries and government in China.
We interviewed Dr. Xianglei Meng, who is Pharmacy expert working as Deputy Director of the Pharmacy Department of a hospital,
consulted the operation process and management system of the pharmacy in China. Beyond that,
we paid a visit to a leading pharmaceutical research companies Genequantum,
talked with Dr. Chong Liu and Mr. Yunpeng Zhong about the policies and laws of biopharmaceutical product approval process and clinical trials in China.
A few years ago, China's biological agent and drugs evaluation system was in an extremely immature state.
The scientific and technological innovation support for pharmaceutical medical devices as not enough,
and there was a gap between the quality of listed products and the international advanced level.
However, after a series of reforms by the State Food and Drug Administration in recent years,
the situation has clearly improved. China's drug regulators regulations are working hard to align with world standards.
Innovative drugs, biological products, drugs that address major public health risks,
and drugs that treat rare diseases have all been included in the priority review channel.
In our questionnaires, interviews and field research, we found the following:
(1) Despite a series of laws and regulations and related policies being declared,
some of them lack detailed implementation rules and specific enforcement regulation,
resulting in the lack of effective guidance for pharmaceutical companies in actual operations.
For example, there are ambiguities and uncertainties in the actual operation of clinical trials’ evaluation and drug approval process and it is complicated and time-consuming.
(2) China's current regulations required that GMP can only be certified to qualified drug manufacturers and associated to products.
Non-certified laboratories or pilot plants are currently considered “non-GMP”.
China requires GMP certification in the first phase of clinical trials of drugs.
Differently, the United States, Canada, and many other countries and regions are exempted from the requirements of GMP for Phase 1.
These problems have posed a dilemma to many drug development companies:
to conduct drug trials in foreign countries or to spend massively in China to work with companies that hold GMP qualifications.
(3) The public has insufficient confidence in biological therapy. According to our survey, not only ordinary people,
but even some doctors are skeptical about biological treatment. After a series of events, public opinion has exerted pressure,
causing the government and hospitals to adopt more cautious approaches to experimental and clinical biotherapy.
(4) Ethical supervision and biosafety supervision need to be strengthened. Due to different cultural backgrounds,
the ethical review of biomedical research started late in China,
leading to imperfect regulations and inefficient ethical review; many researchers lacked knowledge and correct understanding. Similarly, biosecurity is a serious challenge in China and the world. Current regulations do not effectively control the biosafety risks of the entire process of research, production, experimentation, and application.