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.
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.
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.
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.
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.
The China Food and Drug Administration (CFDA) plans to allow online sales of prescription drugs as early as this month, opening up the market to existing online e-commerce platform operators like Alibaba.com and JD.com.
Speculation about a new policy has been circulating since mid-2014. If approved, the policy could lead to the emergence of a market worth more than RMB 1 trillion ($161 billion) as sales shift from hospitals to online pharmacies. The policy will also help reform the Chinese market that has been solely controlled by state hospitals and distributors.
In late 2014, the China Food and Drug Administration (CFDA)’s Order No. 5 regarding administrative measures for the registration of in vitro diagnostic (IVD) reagents went into effect.
The new administrative measures brought about several changes to the regulation of IVDs. For example, certificate validation now lasts for 5 years rather than 4 years. In addition, country of origin requirements have been eased to accept approval in the country of the manufacturing site in addition to approval in the country of the legal manufacturer.
In order to standardize food safety sampling and testing, enhance the supervision of food safety, promote administration by law and ensure the health and life safety of the public, the Administrative Measures for Food Safety Sampling and Testing was adopted at the executive meeting of China Food and Drug Administration (CFDA) on September 29, 2014.
On December 19, 2014, China Food and Drug Administration (CFDA) issued the Administrative Measures for Food and Drug Supervision Statistics (CFDA Order No. 10). The Administrative Measures was adopted at the executive meeting of CFDA on September 29, 2014 and will come into force as of February 1, 2015.