21 March 2016
China to Carry Out Quality and Efficacy Conformity Assessment of Generic Drugs
The General Office of the State Council recently issued the Opinions on Carrying Out Quality and Efficacy Conformity Assessments of Generic Drugs and proposed measures for assessing the quality and efficacy conformity of generic drugs approved for marketing.
Generic drugs have the same active ingredients, dosage form, route of administration and efficacy as their respective innovator drugs. Generic drug quality and efficacy conformity assessments require that generic drugs approved for marketing must be in conformity with the innovator drugs in quality and efficacy and can be used as substitutes of innovator drugs in clinical practice. This will help save medical expenses and will be of great significance in upgrading China's pharmaceutical industry, ensuring the safety and efficacy of pharmaceutical products, promoting the upgrade and structural adjustment of the pharmaceutical industry, and increasing its international competitiveness.
The Opinions require that generic drugs approved for marketing before the new chemical drug registration category became effective must undergo conformity assessment if they have not already obtained approval in accordance with the principle of quality and efficacy conformity with the innovator drugs. Oral solid preparations of generic chemical drugs on the National List of Essential Medicines (2012 version) approved for marketing before 1 October 2007 should complete their conformity assessment before the end of 2018, while those that need to undergo clinical trials for efficacy test have special conditions should complete conformity assessment before the end of 2021. Those that fail to complete the assessment by the designated deadline may not be granted re-registration.
The Opinions stress that drug manufacturing enterprises, as units responsible for carrying out conformity assessment, should take the initiative to purchase reference-listed drugs for studies to ensure that the quality and efficacy of the drugs they manufacture are in conformity with the reference-listed drugs. The generic drugs of domestic drug manufacturing enterprises that have been approved for marketing in the EU, US and Japan may apply for marketing in China as a new chemical drug registration category using the registration documents used abroad and will be treated as having passed conformity assessment after being approved for marketing. Drugs manufactured on the same production line and marketed in China that have also been approved for marketing in the EU, US and Japan will be treated as having passed conformity assessment.
The Opinions put forward a number of policies for encouraging enterprises to carry out conformity assessment. Drugs that have passed conformity assessment will be announced by the China Food and Drug Administration. Drug manufacturers may indicate this on the drug description and label. Enterprises in pilot areas for the system of marketing authorisation of pharmaceutical products may entrust other drug manufacturers to produce the drugs as marketing authorisation holders and shoulder the relevant legal responsibilities after marketing. Pharmaceutical products that have passed conformity assessment will be given appropriate support in medical insurance payment and enjoy priority in purchase and clinical use in medical institutions. When more than three manufacturers of the same pharmaceutical product have passed conformity assessment, those that have not will be excluded from such catalogue for centralised procurement. Technological transformation in manufacturing enterprises that have passed conformity assessment may apply for financial support from the central capital construction investment fund, industry fund and other funds.