The General Office of the China Food and Drug Administration ("CFDA") has recently issued the 2018 Legislation Plan (the "Plan").
The Plan states that a series of legislation programs will be launched in 2018, including three laws, three regulations and 31 rules. As to the scheduled laws, efforts will continue to help introduce amendments to the Drug Administration Law of the People's Republic of China; second, the Decision of the Standing Committee of the National People's Congress to Authorize Launching the Pilot Compensation System for Some Drugs During the Term of the Patent and Exploring Ways of Establishing the Drug Patent Linkage System will be introduced; and third, a revised draft for review will be formed for the Drug Administration Law of the People's Republic of China and be submitted under applicable procedures to the State Council for deliberation. With regard to the planned regulations, efforts will be made to complete drafting amendments to the Implementing Regulations of the Food Safety Law of the People's Republic of China; next, the process to update the Regulations on the Supervision and Administration of Medical Devices will be sped up, and the legislative institution will make all-out efforts to submit the draft amendments to the State Council in the first quarter; and third, the legislative institution will continue to push for the introduction of the Regulations on the Supervision and Administration of Cosmetics as early as possible.