Will New Version of GMP Boost the Veterinary Drugs Industry?

The new version of GMP for veterinary medicines will come into force on June 1.

According to the Ministry of Agriculture and Rural Affairs' Announcement No.293, which came into effect in April 2020, all veterinary drug manufacturers, regardless of being newly built, renovated, or relocated, should meet the requirements of the new version of GMP requirements by June 1, 2022. This policy aims to continuously improve the quality and safety level of veterinary drug products and to promote the high-quality development of the veterinary drug industry. 

The Ministry will organise and carry out a cleaning-up operation on the implementation of the new version of GMP for veterinary drugs. For the manufacturers (including production workshops) that have not passed the inspection and acceptance of the latest version of GMP by June 1, 2022,(1) Stop the production activities of veterinary drugs.(2) Their production license and the approval number of veterinary drug products are cancelled. (3) Stop the commissioned production of veterinary drugs. 

The implementation of the new GMP standard is good news for large-scaled veterinary drug enterprises because they own advanced infrastructure, muscular financial strength, strong R&D ability, and high quality of personnel, which will enable them to meet the new standard first, and thus seize a larger market share and get better opportunities for further development. However, the small and medium-sized enterprises, which account for more than 90% of the total, will face unprecedented pressure. They will either shut down or switch production because they will not be able to reach the GMP requirements on schedule. Even if they have passed the acceptance process, they will lose the vitality of SMEs because of the high cost and decreased competitiveness.

The application and approval for acceptance of the new version of GMP for veterinary medicines have been progressing slowly. According to data from a securities research institute, as of May 12 2022, more than 900 have passed the new version of GMP for veterinary medicines, with close to 730 companies still outstanding.

The slow progress results from the difficulties in scheduled construction, trapped budget for investment and significantly extended construction time, under the influence of epidemic control and environmental policies for three consecutive years. Some industry insiders have argued that the pandemic is a "Force Majeure" and that the government should fully take these factors into account and appropriately postpone the implementation of the policy. 

How will the new policy lead to an optimised structure of enterprises and products? Will quality and safety levels be improved? We will have to wait and see.