Review of Additional Information Essential Use Nomination from China 2013 M o n t r e a l P r o t o c o l M O P 2 3 2 1 2 5 N o v e m b e r 2 0 1 1 B a l i 2 China EUN 2013 ID: 932522
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TEAP/MTOC Addendum ReportReview of Additional InformationEssential Use Nomination from China 2013
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China EUN 2013: Review of additional information (1)
Bilateral discussions during 32nd
OEWG Meeting between China delegation and attending MTOC co-chairsAdditional information supporting China’s nomination provided 31st August for MTOC review, pertaining only to CFC MDIs containing Traditional Chinese Medicines (TCMs) as active ingredientsChina nomination includes 9 tonnes CFCs to manufacture MDIs containing datura metel extract/clenbuterol, and ephedra/gingko/sophoroflavescens/radix scutellariaeMTOC assessment provided in an Addendum Report published early October
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China EUN 2013: Review of additional information (2)
Affordable oral and injectable TCM treatments for asthma have been
available in China for a long time.MTOC sought evidence to test whether TCM CFC MDIs show improved efficacy compared with other TCM asthma treatment forms, such as oral or injectable. Additional information was provided from clinical studies of the effectiveness of the nominated TCM CFC MDIs as anti-asthmatic drugs.Studies for both TCM CFC MDIs indicated the inhalers to be more effective as anti-asthma treatments than the controls selected for use in the studies.
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China EUN 2013: Review of additional information (3)
Traditional Chinese medicine has its own rationale that may not be subjected to the same scientific discipline as modern medicine
.Evidence has not been provided that demonstrates the improved efficacy of TCM CFC MDIs compared with other forms of TCMs for asthma.MTOC does not consider CFCs for this use to be essential under Decision IV/25 due to the availability of suitable alternatives, and is unable to recommend the nominated CFCs for these products.For 2013, China may wish to consider allocating CFCs for these products from within its authorised quantity to allow time for patient transition from TCM CFC MDIs to alternatives.M o n t r e a l P r o t o c o l
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Essential
Uses Recommendations:
Summary
for Metered Dose Inhalers (MDIs)
For Parties nominating CFCs for MDIs:
Authorized for 2012;
Nominated
(Recommended)
for
2013 in metric
tonnes
.
Party
2012
Authorized
2013
Nominated
(Recommended)
Bangladesh
40.35
-
China
532.04
446.52
(386.82)
Pakistan
24.1
-
Russian Fed.
212.0
250
(212.0)
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