China's new GMP rules will lead to industry consolidation
China's new rules on Good Manufacturing Practice is likely to drive consolidation among the country's 5,000-plus pharmaceutical companies, according to legal company Bird & Bird.
The new GMP rules came into effect on 1 March 2011 and "significantly elevates GMP standards in China", according to Bird & Bird's Grace Chen and Weishi Li.
As elevated standards under the new GMP mean higher manufacturing costs for drug companies, it will benefit big drug companies with resources, particularly those who have already adopted higher GMP standards, whereas many smaller companies will likely be eliminated, they note.
The new rules place greater emphasis on the use of effective quality control system by pharmaceutical companies, through the strengthening of drug manufacturing quality management systems.
The new GMP also introduces the concept of quality risk management, and includes a number of significant changes including an increase in employee quality requirements and refinement of China's document management rules to encourage the use of standard operating procedures (SOPs) and manufacturing records.
The updated rules also include new processes and measures for supplier audits, change control, more secure approaches for procurement of excipients and other raw materials, and other measures designed to help prevent and correct quality failures.
Newly established drug manufacturing units, and renovations or expansions of manufacturing facilities by existing drug manufacturing sites will have to comply with the new GMP immediately. However, existing manufacturing facilities have a transition period to come into compliance.
Those manufacturing sterile drug products such as blood products, vaccines and other injectable drug products will be required to comply by 31 December, 2013, while all other facilities will have until 31 December, 2015.
Companies that fail to bring manufacturing sites into compliance within the deadlines will no longer be permitted to continue making their drug products at the facilities.
"These developments will significantly boost the overall quality of China's pharmaceutical industry which will improve the competitiveness of Chinese pharmaceutical companies on the global market", note Chen and Li.