On 29 October 2014, the Centre for Drug Evaluation ("CDE") of the China Food and Drug Administration ("CFDA") published "Draft Technical Guidelines for Research, Development and Evaluation of Biosimilars" (the "Draft Guidelines") for public comments. The Draft Guidelines were published shortly after the announcement of biosimilar guidelines by the FDA and the EMA.
The Draft Guidelines are intended to guide the research, development and evaluation of biosimilars and to promote the development of the biopharmaceutical industry in China. It generally applies to therapeutic recombinant proteins with structures and functions that are distinct enough to permit comparison of the biosimilar with reference products.
Pursuant to the Draft Guidelines, a biosimilar is defined as a therapeutic biological product that is similar in quality, safety and efficacy as the originator CFDA approved drug, and which should have the same amino acid sequence as the originator drug. A reference drug is defined as the originator drug that has been approved by the CFDA and used in the comparative studies with biosimilars. The Draft Guidelines provide that an approved biosimilar cannot itself be used as a reference drug.
The Draft Guidelines consist of 10 chapters including the definitions and scope of application, methodology for the use of reference drugs, basic principles for R&D and evaluation of biosimilars, pharmaceutical studies and evaluation, non-clinical studies and evaluation, clinical studies and evaluation, product specification and pharmacovigilance. The Draft Guidelines on product specification and pharmacovigilance are very general and more elaboration will be needed.
Currently, all biologics in China are treated as new drugs and the registration process can take up to 4-6 years. The publication of the Draft Guidelines by the CDE is a strong indication that the CFDA is considering a separate approval procedure for biosimilars. At this stage, it is unclear how such a procedure would be integrated into the existing legal framework set out in the Drug Administration Law and the Drug Registration Rules.
The consultation period for the Draft Guidelines concluded on 29 November 2014. Although the CFDA has not announced when the Guidelines will be implemented, it is expected that they will be in place in 2015.
CFDA seeks public comments on Medical Device Manufacturer Guidelines
On 3 December 2014, the CFDA released a draft consultation paper on the Medical Devices Manufacture Supplier Audit Guidelines (the "Supplier Audit Guidelines") in accordance with the Measures for the Supervision and Administration of Medical Device Production and GMP for Medical Devices.
According to the Supplier Audit Guidelines, medical device manufacturers should establish a review system for supplier audit and evaluation to ensure that products of procurement can meet relevant regulatory requirements. The Supplier Audit Guidelines consist of 5 parts, including the scope of application, principle of audit, scope of audit, main aspects of audit and other requirements.
The Supplier Audit Guidelines will apply to all medical device manufacturers in China and their management of suppliers. A supplier has been defined in the Supplier Audit Guidelines as an entity or organisation that supplies goods and services to medical device manufacturers.
The consultation period for the Supplier Audit Guidelines concluded on 10 December 2014. Although the CFDA has not announced when the Supplier Audit Guidelines will be implemented, it is expected that they will be in place in 2015.
SIPO launched trial patent data service for patents in 5 countries
On 10 December 2014, the Chinese State Intellectual Property Office ("SIPO") launched a trial of a patent data service system that provides a free FTP download service for basic information of patents in China, United States, Europe, Japan and Korea.
Users of the trial system are required to register with one of the databases available under the trial, and sign a Data Usage Policy before a FTP download permission is granted to the user.
Further information and access to the trial service can be found at http://patdata.sipo.gov.cn/.