To guide and standardize the similar biological medicine research and development and evaluation work, promote the healthy development of the biomedicine industry, a few days ago, the state food and drug supervision and administration bureau issued similar to the biological medicine research and development and evaluation of technical guidelines (try out) "(hereinafter referred to as the" guidelines "), for similar biological medicine program, class, and declare the personal data and other related registration requirements in the specification.
Biological analogies refer to the therapeutic use of biological products in terms of quality, safety and efficacy with the reference drugs that have been approved for registration.
Due to the similar biological medicine can better meet the public demand for biological treatment product, help to improve the accessibility of biological medicine and reduce prices, many countries have attached great importance to similar biological medicine research and development and management, or more than 20 countries around the world to make a similar biological medicine related guidelines.
For domestic and foreign pharmaceutical production enterprise in our country to carry out similar biological medicine research and development of a strong will, in order to promote the healthy and orderly development of biopharmaceutical industry in China, the state food and drug supervision administration organization drug approval center and other technical department in time, in reference to the world health organization and the domestic and foreign relevant guiding principles and international biological similar drug research and development of successful cases, on the basis of fully solicit opinions and listen to the expert inside course of study and enterprise, combining the actual situation of our biological medicine research and development and the specific national conditions, in line with both to ensure that similar biological medicine similarity with the original drug, at the same time can reduce the development time and cost of enterprise principle, completed the "guiding principles" of the drafting work.
"Guiding principles" clear the definition of similar biological medicine, put forward the basic principles of biological medicine research and development and evaluation of similar, for similar biological medicine pharmacy, non-clinical and clinical research and evaluation content such as specific requirements are put forward.
"Guiding principles", marked the evaluation of the biological similar to the drug administration are available in the following basic principles, in order to further standardize the drug research and development, improve the level of its security, effectiveness and quality control has laid a good foundation.
State food and drug supervision bureau will carry out according to the guiding principles in the process of the new situation, new problems, and timely amend, further refine the relevant evaluation standard and requirements, in order to better encourage the development of high level quality similar biological medicine, promote the healthy development of Chinese bio-pharmaceutical industry.