Draft guidance on CDER’s program to recognise standards in pharmaceutical quality

A draft guidance has been made available for industry entitled CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.  This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognised voluntary consensus standards related to pharmaceutical quality.  

This program, once established, should facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. This informal program will help streamline the compilation and assessment of marketing applications for products regulated by CDER. The applicant’s use of an informally recognised consensus standard will be strictly voluntary. CDER also believes that this program will: 

• Allow CDER to communicate to external stakeholders that its relevant expert(s) have evaluated a consensus standard and determined if that standard is potentially useful both to industry and CDER staff and 
• Provide transparency to industry regarding CDER’s thinking about a method or approach. 

CDER is issuing this draft guidance to obtain public comments on the proposed program.  the Agency is encouraging interested parties to submit comments. CDER will consider comments submitted to the docket when establishing the program and publishing a final guidance.  Once the guidance has been finalised, CDER will start accepting submissions to recognise voluntary consensus standards.

The draft guidance introduces the program and the scope of the program. 

It recognises that the proposed program will allow CDER to use Agency expertise to evaluate and informally recognise voluntary consensus standards related to phamaceutical quality that are potentially useful to industry and CDER staff.

The process will allow CDER to receive a candidate consensus standard to determine whether to informally recognise a standard in whole or in part following an initial scientific evaluation.  It will also list the informally recognised standards in a publicly searchable database on CDER’s website, accompanied by an information sheet describing the scope and the extent of the informal recognition of the standard and relevant information about it.

The full draft guidance can be found here.