Republic of China’s State Federal Drug Administration (SFDA) is now all set to issue a set of stringent norms to clamp down poor quality standards in drug production. It has also released a guidance on the on effective utilization of adverse drug reaction (ADR) monitoring data. The notice requires to make effective analysis, evaluation and utilization of ADR monitoring data, enhance the responsibility awareness and risk awareness of manufacturing enterprises and further strengthen daily management of ADR monitoring.
Further, it has also defined time limits for ophthalmic preparations and related products to meet the requirements of newly revised GMP.
In accordance with the notice, intraocular injections, ophthalmic inserts, ophthalmic preparations used in surgery and treatment of wound and penetrating injury of cornea as well as ophthalmic liquid preparations would need to meet the requirements of the newly revised GMP before December 31, 2013. Other ophthalmic preparations will be needed to meet the requirements of the newly revised GMP before December 31, 2015. In addition, all the other preparations and drug substances which are subject to sterility test items as required in the official drug standards should meet the requirements of the newly revised GMP before December 31, 2013; In vitro diagnostic reagents regulated as drugs should meet the requirements of the newly revised GMP before December 31, 2015.
The new set of regulations may sound like an alarm bell for the pharma industry in China. But this will see only quality and serious players in the market. There is no room for fly-by night operators, Yong Kuang, vice president, Reed Sinopharma Exhibitions told Pharmabiz in an interaction.
The country will need to gear up to prove its expertise to gain its market share in the global arena. Right now India and China are the big players in the pharma space. China’s industry is far behind dossier submission and filing drug master files. India has the edge because of its English speaking qualified population. It will take a while for the country to catch the bus, he added.
Together with the regulation, the Republic of China has announced its focus on pharma under the 12 five year plan programme. The objective is the create an environment of professionalism in a knowledge driven economy. Strong internationalisation is the roadmap for China, stated the reed Sinopharm VP.
Currently, there are over 4,000 finished drug manufacturers and a similar number of active pharma ingredient manufacturers. The new era for the pharma industry in China after the regulations are issued would provide ample scope for mergers and acquisitions. The international market has recognised the capability of China and India pharma companies, said Kuang.
In the wake of the new SFDA norms, Basu Agarwal, marketing head, Agarwal Aromatics, the reality is that pharmaceutical industry in India and China are eyeing for an economic cooperation which could boost the trade relations between the two countries.