新修订《中华人民共和国药品管理法实施条例》将于5月15日起施行（附全文）

Group 1 - The revised "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" will take effect on May 15, 2026, and consists of 9 chapters and 89 articles [1] - The regulations aim to enhance drug research and registration systems, supporting clinical value-oriented drug development and innovation, and encouraging new drug research and clinical promotion [1][6] - A fast-track registration process for drugs has been established, along with clear re-registration procedures and mechanisms for converting prescription drugs to over-the-counter drugs [1][26] Group 2 - Drug production management will be strengthened, with clear responsibilities for drug marketing authorization holders during contract manufacturing [2] - The regulations specify management requirements for traditional Chinese medicine (TCM) decoction pieces and formula granules [2] Group 3 - Drug safety supervision will be strictly enforced, with detailed measures for quality inspection and legal responsibilities for violations [3] Group 4 - The regulations support the development and innovation of drugs for children and rare diseases, providing market exclusivity periods of up to 2 years and 7 years, respectively, for qualifying products [26][28] - Data protection for drugs containing new chemical entities will be implemented, preventing unauthorized commercial use of undisclosed trial data for up to 6 years [29]