Pharmaceutical Working Group Meeting Go back »
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Time2006-04-26 | 14:00
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Venue:European Chamber Office, Beijing
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Address:S-123 Beijing Lufthansa Center, 50 Liangmaqiao Road
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Fee:Members: FREE |
Non Members: FREE
To confirm your attendance please contact Ms. Rhian Kelly at rhiankelly@euccc.com.cn.
Kindly note that the meeting is open for members only. For further information about Working Group or how to become a member, please contact Business Manager Mr. David Lee at dlee@euccc.com.cn in Beijing or Mr. Tony Brooks at tbrooks@euccc.com.cn.
Event review
Pharmaceutical Working Group MinutesWednesday 26th April 2006, 2pm
European Chamber Office (Beijing & Shanghai)
Author: Rhian Kelly (rhiankelly@euccc.com.cn)
Participants:
Beijing
Company |
Name |
Chamber Member |
CJB China Ltd |
Christopher J. Baron |
X |
Fresenius Kabi |
Bryan Xue |
X |
GSK |
Jan Fang |
X |
Ipsen |
Eric Bouteiller |
X |
Interfax |
Howard Zheng |
X |
EU Chamber |
Ms. Rhian Kelly |
X |
Shanghai
Company |
Name |
Chamber Member |
DSM |
Annie Zhu |
X |
Solvay Pharma |
Christian Grapow |
X |
Novo Nordisk |
Iris Yan Tang |
X |
EU Chamber |
Andrew Douglas |
X |
Agenda
1. Working Group Elections
2. Presentation on API Imports into China by Annie Zhu, DSM
3. Position Paper 2006
4. Industrial and scientific policy development
5. Update from Market Authorisation Workshop
Discussion points
1. Working Group Elections
The Chairperson, Eric Bouteiller, was unanimously reaffirmed. Christian Grapow was also elected as Vice-Chairperson.
Eric Bouteiller thanked everybody for confidence in him. He took the opportunity to invite every member of the Working Group to participate actively in the meetings, express concerns rising from day-to-day operations and to provide input to the Position Paper.
The Chairperson then chaired the rest of the meeting.
2. Presentation on API Imports into China by Annie Zhu, DSM
Annie Zhu provided an interesting presentation on the importation of active pharmaceutical ingredients (API) into China. This is an issue that the Working Group has previously looked into and was one of the key concerns outlined in the 2004 Position Paper. Since then there has been little change in the situation by SFDA. The presentation outlined three main concerns:
1. Stricter quality standards imposed on imported products compared to those for local producers
2. Unreasonably high charge for “port inspection” of imported API’s. There is no cost for local producers.
3. Original/original copy of IDL needs to be presented at the port of Customs.
The presentation was summarized by three recommendations:
1. Apply Chinese Pharmacopoeia equally to local producers and importers
2. Adopt random testing, decrease the samples to be taken from one batch and apply a free-of-charge inspection policy equally to importers and local producers
3. Accept copy of IDL authorized by importer instead of asking for the original /original copy at the port After the presentation there was discussion on who to directed this issue towards. Members agreed that both SFDA and MOFCOM ought to be addressed. MOFCOM should be included because this is a market access issue. Many of those present agreed that this was a concern but not a top priority – many ingredients are sourced locally. It was agreed to keep this issue in mind and mention it inside the Position Paper, although it will not be a key topic of concern.
3. Position Paper 2006
The 2006 Position Paper will take a similar format to the 2005 Position Paper with the exception of no list of company names at the end of the paper. It was agreed that the key recommendations should be kept to a maximum of six and that in fact many of the recommendations from the last paper are still relevant. However, the environment has changed since last year and this needs to be reflected in the recent progress section.
The deadlines are as follows:
Friday 12th May 2006 2-3pm (tbc): teleconference with Chairperson, Vice-Chairperson regarding initial drafting Friday 9th June 2006: circulate first draft of the Paper
Friday 16th June 2006: Pharmaceutical Working Group meeting to discuss the draft Position Paper
4. Industrial and scientific policy development
In future it could be more productive to start a discussion with key officials on the long-term development of the pharmaceutical industry in China, the policy for innovation. To move this forward the Chamber will work to identify the key policy level people in NDRC and MOST. Once the Position Paper has been produced it will be necessary to present this to them to kick-off dialogue.
5. Update from Market Authorisation Workshop
The upcoming workshop has been confirmed and will now take place in the week 18th September. More details will be made available shortly. The aims of this workshop are to establish a long-term cooperation with the SFDA, to facilitate the establishment of a market system all over China. SFDA has expressed an interest in this. The long-term aim is to convince the SFDA to open their market regarding toll manufacturing, co-manufacturing, co-promotion and co-marketing. There will be an update form RDPAC at the next meeting.
6. Next Meeting
The next Pharmaceutical Working Group meeting will be held on Friday 16th June 2006 at the European Chamber offices in Beijing and Shanghai from 2 to 4pm.
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