Task A: Good Registration Management (GRM)

Concept

The concept of GRM is to promote both GRevP by the reviewers and GSubP by the applicants cooperatively.

One of the key messages of GRM is to keep close communications between review authorities and applicants during product registration process.

Good Review Practice (GRevP)

Promoted by regulatory authorities under APEC RHSC topic to enhance quality, transparency, timeliness, predictability of application review.

GRevP Guideline for national and regional regulatory authorities was endorsed by WHO

Good Submission Practice (GSubP)

Industry initiative in response to GRevP to enhance quality of application submission and its management aiming to obtain early approval

RA-EWG developed the APAC GSubP Guideline as a high level guidance document for applicants of new drugs

Stakeholders

APEC-LISF

WHO

RA-EWG member associations (Please refer to “Link”)