China has long been complained about by multinational and Chinese domestic pharma companies for its time consuming process to evaluate and approve new drugs: usually five years to 10 years, compared with 20 months on average in the US.
While China’s food and drug administration (CFDA) explains part of the reason for the slow process is it only has less than 200 staff to review all the drug applications, compared with 4000 in the US FDA, it is keen at shaking off the reputation and encouraging the development of more innovative drugs.
The CFDA has already taken some steps to make improvement. A recent example is the new policy on pediatrics.
According to the industry watch dog, applications of novel pediatrics will be evaluated prior to other candidates as long as they have significant therapeutic advantages over the drugs in use, or could treat fatal symptoms or the diseases that could affect children’s growth.
Urgent generics
For generics, if the applied drugs are in urgent need they will also be taken precedence. But if a company offers a different dosage form and wish to be evaluated as soon as possible, it has to make sure this dosage form is the only one in the Chinese market designed for pediatric use.
On January 29, the CFDA released the first batch of applications that will enjoy the new policy, which means they will be launched in the Chinese market faster than other applied new drugs.
The four new candidates are: clofarabine injection (20ml;20mg) for leukemia from Hangzhou-based Betta Pharma, caffeine citrate injection (1ml;20mg) for breathing problems among premature infants from Chengdu-based Easton Pharmaceutical, propranolol hydrochloride oral solution (120ml;0.5136g) from Wuhan-based Conform Pharm for heart rhythm disorders, as well as the antibiotics faropenem dry syrup (0.05g) from Osaka-based Maruho for penicillin-resistant Streptococcus pneumonia.
Pediatrics are overall in great shortage in China, accounting for merely 1.7% of over 3500 drug types in total, according to the CFDA.