The Central Committee of the Communist Party of China (CPC) and the State Council pay great attention to the guarantee of medication for children. On May 30, the NHFPC, the National Development and Reform Commission (NDRC), the Ministry of Industry and Information, the Ministry of Human Resources and Social Security, the State Food and Drug Administration (SFDA), and the State Administration of Traditional Chinese Medicine held a joint media briefing in which efforts were made to publicize and interpret the document entitled Several Opinions on Guaranteeing Medication for Children (hereinafter referred to as the Opinions) jointly issued by several departments and sanctioned by the State Council.

At present, with the rapid development of medicine and healthcare in China, the health level and the medication level of children has been gradually upgraded, and the basic medication for children has markedly improved. However, we must be keenly aware of the fact that: pediatric drugs are, in terms of applicable types, dosage forms and specifications, not adequate; enterprises lack motivation to do R&D and production enthusiasm; the problem of irrational administration of drugs still exists; and the safety of medication for children faces challenges.

In the Opinions, specific requirements for guaranteeing medication for children are made clear as to the encouragement of R&D and creation and preparation of new drugs, the speedy process of new drug application and review, the guarantee of supply, stricter quality supervision, the promotion of rational administration of drugs, the improvement of systemic construction, and the upgrading of overall capabilities. This document is the first comprehensive guiding document in China in more than 10 years concerning medication for children.

In terms of application & review, R&D, creation and preparation of new drugs, it is stipulated that a special channel will be designated to handle application and review of some urgently needed clinical pediatric drugs that are applicable to children in terms of types, dosage forms and specifications to speed up the process. A catalog of pediatric drugs should be gradually prepared so as to guide and encourage enterprises to give priority to R&D and production of those on the catalog; While doing new drug application, the responsible party should provide the data on clinical trials on children and drug information should be explored. Pharmaceutical production enterprises should, on a timely basis, provide or add data on clinical trials on children of drugs that have gone on sale.