August 21, 2009
First Chinese CRO Industry Standard Under Development
According to information from the CRO Union (CROU) under the China National Pharmaceutical Technology Market Association, it is developing the first industry standard for the Chinese CRO sector, Guidelines for Clinical Trial Services of Contract Research Organizations. Currently drafting of the document is already completed and it is likely to be introduced before the end of this year.
The Guideline was formulated with references to relevant WHO documents, ICH-GCP, the Drug Administration Law of China, Provisions for Approval of Drugs, and Guidelines for Quality Control of Clinical Trials (Chinese GCP), according to Gong Yanhua, Secretary General of CROU.
A technical work group and an academic advisory group were formed under CROU to guide the development of the Guideline. Members of the technical work group are mostly experts from leading clinical CRO such as Quintiles and Pharmanet, while those of the academic advisory group are mostly representatives of MNC and leading local pharma companies. As its next step, CROU hopes to establish a technical committee for standardization of clinical trial services of Chinese CROs soon.
The draft of the Guideline was already reviewed by experts in the field and representatives of CRO firms at a recent CRO industry event and consensus was formed, Gong revealed.
"The industry standard will help strengthen operation and service management of Chinese CROs and thus raise the competitiveness of the sector", Gong said.
Following introduction of the Guideline, CROU plans to lead the development of a certification system for Chinese CROs which is similar to ISO9000. Initial preparations have already begun, said a CRO executive who is an active constituent of CROU.