Posts Tagged ‘Malaysia’

Kinesisk örtmedicin

måndag, december 10th, 2012

Det första ” International Symposium on Regulation of Traditional Chinese Medicines” har genomförts i Peking. WHO var där, Danmark var där.

On December 4-6, 2012, the 1st International Symposium on Regulation of Traditional Chinese Medicines, sponsored by the State Food and Drug Administration (SFDA), was held in Beijing. SFDA Commissioner Yin Li attended the opening ceremony and delivered a speech. SFDA Deputy Commissioner Bian Zhenjia was present at the symposium and made concluding remarks. More than 200 representatives attended the symposium, including representatives from WHO, drug regulatory authorities and embassies of 18 countries and regions such as EU, France, the United Kingdom, Denmark, the Netherlands, Latvia, Poland, the United States, Canada, South Korea, Brunei, Malaysia, Philippines, Singapore, Thailand, Hong Kong and Macau, representatives from the State Administration of Traditional Chinese Medicine, food and drug regulatory departments of the relevant provinces, and representatives from academic and industry sector. During the symposium, the supervision system, laws and regulations, and technical requirements of traditional Chinese medicines were introduced, and the participants exchanged views on development and innovation of traditional Chinese medicines and each country’s experience on supervision of herbal medicines.

 

Höj blicken!

torsdag, november 24th, 2011

Harmonisering av regelverk inom det medicintekniska området fortskrider. Det betyder att vi får lättare att göra affärer runt hela Globen. Här gäller det att stå på tå! Självklart kommer också konkurrensen att öka.
Global Harmonization Task Force känner säkert alla till.
Men kanske inte Asian Harmonization Working Party.
AHWP:
”Asian Harmonization Working Party (AHWP) is established as a non-profit organization. Its goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions and to work in coordination with the Global Harmonization Task Force, APEC and other related international organizations aiming at establishing harmonized requirements, procedures and standards.”

De länder som samarbetar inom AHWP är; Abu Dhabi Brunei Darussalam, Cambodia, Chile, Chinese Taipei, Hong Kong SAR, China, India, Indonesia, Jordan, Kingdom of Saudi Arabia, Korea, Laos, Malaysia, Myanmar, Pakistan, People’s Republic of China, Philippines, Singapore, South Africa, Thailand, Vietnam och Yemen.
Imponerade!
Några av de guidance-dokument som har antagits inom AHWP;
”The Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers”
”Safety Alert Dissemination System (SADS) and Survey Post Market Surveillance System”.
I arbetsgrupperna inom AHWP finns de stora globala medicinteknikföretagen representerade. Exempelvis GE Healthcare, Johnson & Johnson Medical, St Jude Medical, Toshiba Medical System, Boston Scientific, Philips, Kimberly Clark, 3M, Medtronic, Abbott, Hill-Rom, Bard Medical Devices, Cochlear och Molnlycke Health Care.

Det är ju självklart att de stora företagen slår vakt om sina intressen i dessa sammanhang. Det kan vara dags för de svenska medicintekniska företagen att höja blicken så den når längre än till EU!