New industry standards for medical devices in China
On Dec. 27, 2010, China’s State Food & Drug Administration (SFDA) website was updated with an announcement on 96 new industry standards that will affect medical devices in China. 34 of these new industry standards are mandatory (labeled YY) while the remaining 62 are recommended (labeled YY/T). The mandatory standards will be regulated beginning June 1, 2012.
Several of the mandatory industry standards are replacing other standards. For example, YY 0054-2010 for hemodialysis equipment will be replacing YY 0054-2003, and YY 0333-2010covering soft tissue dilation devices will replace YY 0333-2002. However, many others are new, such as YY 0804-2010 for medical fluid metastatis.
The recommended industry standards cover sterile medical equipment packaging testing methods, dental root canal devices, orthopedic transplant devices, and more.
The full list of new industry standards in China can be found through this link. (Chinese only).
Indian Ministry of Health drafts notification regarding CTD preparation
India will soon be adopting a Common Technical Document (CTD) for the import, manufacture and marketing approval of new drugs. India’s Union Ministry of Health has produced a draft notification for the preparation of the CTD. The new format will be implemented to create greater ease of use, to prevent omission of important data or analyses, and to improve speed of review. Using the CTD is expected to reduce the time and resources required to compile global applications for registration by a significant amount. Until now, applicants have used many different formats for the filing of their application materials, making the review process difficult and time consuming.
In addition to raising the Indian standard of quality, the CTD will create structure across the entire application filing process and prevent approval delays.
Japan, the European Union, the United States and others have already adopted a CTD format. Though India has already used such a system for biological products since 2009, this will be the first time the CTD will be used in India for pharmaceutical products.
Philippines to adopt ASEAN common technical dossier and common technical requirements soon
The Philippines will soon be adopting the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for pharmaceutical registration. There is currently no set date for this implementation, but the Department of Health has already released a draft administrative order. Pharmaceutical manufacturers, traders, exporters, exporters, importers, and wholesalers would all need to abide by this new administrative order when fully executed.
The ACTD has multiple sections including a glossary, table of contents, quality data, nonclinical data and study reports, clinical data and study reports and more. The ACTR includes guidelines on the drug’s stability study, manufacturing process validation data, validation of analytical procedures, conduct of bioavailability and bioequivalence studies, etc.
The aim is to improve the state of public health by allowing more effective drugs to reach the Filipino population sooner. These changes should streamline the drug registration process in the Philippines.
New agreement between Taiwan and China promotes drug development
On Dec. 21, 2010, representatives from Taiwan and China met to sign a new agreement that supports the bio-technology industries of both territories. Two important outcomes of this agreement include upcoming cooperation on clinical trial standards and vaccine development.
With clinical trial standards developed in agreement between Taiwan and China, the two areas hope to accelerate the process of obtaining market clearance for certain pharmaceuticals. At the moment, drugs that have undergone product registration with clinical trials in Taiwan or China usually have to be submitted for clinical trials in the other territory. However, the forthcoming clinical trial standards would no longer require the repeat of clinical trials. In the future, for instance, drugs that have clinical trial data from Taiwan will not need to repeat trials in China to sell in the new market and vice versa.
The director of Taiwan’s Food and Drug Administration (TFDA), Kang Jaw-Jou, has stated that Taiwanese officials might review clinical trial and other facilities in China to certify that there is satisfactory compliance with Taiwan’s guidelines on quality.
In addition to the collaboration on clinical trial standards, both sides have also agreed to work together on creating and improving vaccines to further enhance public health.
