Chinese Premier Li Keqiang recently announced that China will cancel most of the drug price controls, so that the price will be determined by the market given – even though a specific timetable has not been determined. China may also make profit-margin regulations, and the price cap to ensure that the medicines available and affordable. This policy change is because China is working to strengthen the supervision and control of the pharmaceutical sector in order to improve the quality of drugs, increase transparency, and promote the development of domestic pharmaceutical companies. In addition, the government may soon allow the drug can be sold through online pharmacies. Drug consumption accounts for about 45% of China’s health spending in 2014.
China Releases Biosimilar Guidelines
The China Food and Drug Administration (CFDA) released the country’s first biosimilar guidelines on February 28, 2015. The final guidance, based on a draft released in November 2014, took into effect immediately.
Premier’s report may boost China’s medical Internet development
Chinese Premier Li Keqiang in his recent government work report mentioned the need to accelerate and improve basic health care system, and continuously improve the level of health care, to create a healthy China.
China Releases Draft Revised Pharmaceutical Good Clinical Practices
The China Food and Drug Administration (CFDA) has announced draft revisions to its pharmaceutical Good Clinical Practices (GCP) . The revisions will add additional responsibilities and requirements to the current GCP regulations, which were enacted in September 2003. The new regulations are roughly similar to the International Conference on Harmonization (ICH) guidelines, so Western companies should not be significantly affected by the changes.
CFDA will allow medical devices companies to own online shops
This year China Food and Drug Administration will permit medical device companies to open online shops. Medical device companies can operate in the online business after applying to get a medical device Internet license. Prior to this change, currently the medical devices are only allowed to buy or sell in online pharmacy stores, and medical device companies are not allowed to have their own online stores.
Shandong Qidu Pharmaceutical was ordered to suspend business
Regarding the “hair” alike visible particles in Levofloxacin Hydrochloride and Sodium Chloride Injection produced by Shandong Qidu Pharmaceutical Co., Ltd., the local CFDA, Food and Drug Administration Zibo City, has measured out a severe punishment and ordered Shandong Qidu Pharmaceutical Co., Ltd. to suspend business for internal rectification, after the on-site inspection.
China’s policy of prescription drugs online sales is finalized for 200+ products
“Supervision and Control Rules for Food and Drug Management on the Internet” (hereinafter referred to as the “Rules”) medicine electricity traders eagerly awaited has been officially finalized. The Rules is expected to be announced shortly. Policy of prescription drugs online sales will soon be settled. The first batch of more than 200 products may be included. The e-commerce development of pharmaceutical industry will spurt.
China eyes sourcing anti-cancer drugs from Guj
At a time when Indian pharmaceutical’s over-dependency on Chinese market for raw materials is a rising concern, Chinese companies are showing interest in sourcing medicines from India, especially anti-cancer drugs from Gujarat.
CFDA investigated visible particles for Injection of Shandong Qidu Pharmaceutical
Recently, the media reported that a clinic in Changchun city found a bottle of injection have the “hair” alike visible particles problem. Jilin Food and Drug Administration are carrying out in-depth investigation. China Food and Drug Administration (CFDA) paid high attention to the quality and safety issues, and sent investigation teams to Changchun and the drug manufacturer to verify the circumstances of product and patients. The investigation teams have conducted a comprehensive on-site inspection for the production enterprise of Shandong Qidu Pharmaceutical Co., Ltd.