Recently, the China Food and Drug Administration ("CFDA") has issued the Administrative Measures for Key Laboratories (the "Measures"), with immediate effect from the issue date.
The Measures stipulate that key laboratories should run the director accountability system led by entities they are affiliated to and the operating mechanism characterized by "openness, mobility, joint efforts and competition", and adopt the management mechanism of "regular evaluation and dynamic adjustment". Meanwhile, the Measures clearly specify that the director of a key lab should be responsible for proposing the construction and development plans for such lab and organizing the implementation thereof, deciding on the research areas and focuses of the laboratory according to food and drug regulatory needs, etc. Furthermore, each key laboratory should generally have at least 20 persons, including in-service employees and mobile personnel. Additionally, qualification as key labs will be granted by assessment which should be conducted under the principle of "filing applications voluntarily and assessing applicants based on merits ". Also, the Measures require that key labs should intensify opening up to the outside world and strengthen the protection of intellectual property rights.