Secondly Proposed Technical Guidance: IVD Reagents for Detection of HIV, HBV-DNA and Specified IgM Antibodies to Pathogen

As we know, the main purpose of technical guidance is to standardize the requirements for registration and application documents. It is important to corresponding registration and application entities. In general, the official technical guidance will be issued after two rounds of public comments. These issued Second Draft Documents are given a typical demonstration of this rule.

CMDE has carried out a series of activities for public solicitation, the brief process is:

From 9 to 15 March 2012, CMDE solicited the manufacturer information of the mentioned above three IVD reagents;

From April 28 to June 15, 2012, CMDE issued the draft guidance for the mentioned three IVD reagents for public comments firstly.

From September 13 to October12, 2012, CMDE issued second draft guidance amended with the public comments on first draft.

The overall framework of Second Draft Documents is same as First Draft. And two version drafts are both standardized the requirements of contents and format of registration and application documents in detail. Corresponding entities and individuals should pay close attention to the amendment to your own comments or problems and the different between the two version drafts. Moreover, the corresponding entities and individuals should analyze the trend of the upcoming official guidelines in order to adjust corresponding products registration plan timely. Besides, applicants should prepare registration and application documents in the order of the table of content and complied with the detail requirements of each part in the Second Draft Documents. In addition, applicants should make sure that the application documents comply with regulation and requirements mentioned in Second Draft Documents.

We strongly suggest related entities, organizations and individuals paying attention to these Second Draft Guidance Documents and actively providing related comments. On the other hand it is recommended to compiling the application documents, subject to Second Draft Guidance Documents. And meanwhile, we suggest tracking the update of guideline documents in order to adjust the registration and application documents in time so as to improve the compliance of products, effectively reduce risk of product registration, save time, control cost and obtain the approval of product marketing eventually.