CFCs used as dispersant and propellant as part of medicinal aerosols are among the substances that according to the Vienna Convention for the Protection of the Ozone Layer shall be phased out by 2010. Currently, There are ten ODSs under control in China. CFCs in medicinal aerosols are mainly CFC11, CFC12 and CFC114
The Chinese government joined Vienna Convention for the Protection of the Ozone Layer in September 1989 and Montreal Protocol on Substances that Deplete the Ozone Layer ("Montreal Protocol") in June 1991 to protect the ozone layers. According to China National Plan for Phasing out Ozone-Depleting Substances approved in January 1993 by the State Council, China will have phased out the manufacturing and consumption of ozone-depleting substances (ODS) by January 1, 2010.
CFCs used as dispersant and propellant as part of medicinal aerosols are among the substances that according to the Vienna Convention for the Protection of the Ozone Layer shall be phased out by 2010. Currently, There are ten ODSs under control in China. CFCs in medicinal aerosols are mainly CFC11, CFC12 and CFC114. To fulfill the commitment of the Chinese government and ensure the smooth implementation of the plan, the State Food and Drug Administration (SFDA) issued a notice on June 22, 2006 that specified details relating to the phasing-out of CFCs in aerosols.
As of July 1, 2007, CFCs will be banned as excipients in manufacturing external-use aerosols. However, if they are manufactured before July 1, 2007, external-use aerosols using CFCs as excipients may continue to be circulated and applied until they expire in validity. As of January 1, 2010, CFCs will be banned as excipients in manufacturing inhalant aerosols, and if they are manufactured before January 1, 2010, inhalant aerosols using CFCs as excipients may continue to be circulated and applied until they expire in validity.
As of July 1, 2007, the imports of external-use aerosols using CFCs as excipients will be banned. However, if they are imported before July 1, 2007, external-use aerosols using CFCs as excipients may continue to be circulated and applied until they expire in validity. As of January 1, 2010, the imports of inhalant aerosols using CFCs as excipients will be banned, and if they are imported before January 1, 2010, inhalant aerosols using CFCs as excipients may continue to be circulated and applied until they expire in validity.
As of July 1, 2007, SFDA will stop approving the registration application (including import application), for external-use aerosols using CFCs as excipients. As of January 1, 2010, SFDA will stop approving the registration application (including import application), for inhalant aerosols using CFCs as excipients.
According to the notice, drug manufacturers shall submit registration application in accordance with the Provisions for Drug Registration for changing excipients for medicinal aerosols or changing dosage form to phase out CFCs as part of the implementation of the National Plan.
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