Email Service Notes (Tony)

Your Original Email

An email from work】

Hi Helen,

Thanks for your comment. Please see attached the updated deck. Following slides are updated: Slide 14, 15, 22, 24, 26.

Slide 12: Rachel Yang shared the latest version of the chart with me, which is the same with chart in the original deck.
Slide 23: The original map was produced based on MENET database which we currently do not have access to, unless we purchase for the latest data.
Slide 27: “A box” is one time use after unprotected sex , e.g.: For Gold Yu Ting, 1 box = 1 tablet with 1.5 mg levonorgestrel.

In addition, all ulipristal acetate (UPA) pipeline products are still under trial in China, and there is no UPA product registered in China yet. For the OTC registration regulations, please see blow the research memo.

If you have any comments or anything else I can help with, please let me know. Thanks.

Best regards,
Sue

==
Research Memo
subject: OTC (On-the-counter) drugs registration regulation
• CFDA released Provision for drug registration in 2007, and OTC registration is regulated in section 7
• OTC has the same application procedure as Rx, but upon submitting the electronic application, the applicant should note “apply for OTC” in “additional terms”
• Drugs satisfy any of the following conditions can be registered as OTC
– A CFDA approved OTC drug modifies dosage form, but does not change the indication or function indication, the dosage and the route of administration;
– Use a new compound preparation consisting of the active ingredients of CFDA approved OTC drugs
• Imported OTC drugs are subject to the declaration and approval procedures for imported drugs, and their technical requirements are the same as those for domestic OTC drugs
• It is not compulsory to register as Rx first and convert to OTC afterward – levonorgestrel and mifepristone were both OTC when first registered in China ( the discussion on direct registration of OTC in China is very limited, so this assumption is made based on the registration conditions of the benchmark molecules: levonorgestrel and mifepristone )

Your Edited Email

An email from work

Hi Helen,

Thanks for your comment. Please see the attached updated deck. The following slides are updated: 14, 15, 22, 24, 26.

Slide 12: Rachel Yang shared the latest version of the chart with me, which is the same as the chart in the original deck.
Slide 23: The original map was produced based on MENET database which we currently do not have access to, unless we purchase the latest data.
Slide 27: “A box” is one time use after unprotected sex , e.g.: For Gold Yu Ting, 1 box = 1 tablet with 1.5 mg levonorgestrel.

In addition, all ulipristal acetate (UPA) pipeline products are still under trial in China, and there is no UPA product registered in China yet. For the OTC registration regulations, please see the research memo below.

If you have any comments or anything else I can help with, please let me know. Thanks.

Best regards,
Sue

==
Research Memo
subject: OTC (On-the-counter) drugs registration regulation
• CFDA released Provisions for drug registration in 2007, and OTC registration is regulated in section 7
• OTC has the same application procedure as Rx, but upon submitting the electronic application, the applicant should note “apply for OTC” in “additional terms”
• Drugs meeting any of the following conditions can be registered as OTC
– A CFDA approved OTC drug modifies dosage form, but does not change the indication or function indication, the dosage and the method of administration;
– Use a new compound preparation consisting of the active ingredients of CFDA approved OTC drugs
• Imported OTC drugs are subject to the declaration and approval procedures, and their technical requirements are the same as those for domestic OTC drugs
• It is not compulsory to register as Rx first and convert to OTC afterward – levonorgestrel and mifepristone were both OTC when first registered in China ( the discussion on direct registration of OTC in China is very limited, so this assumption is made based on the registration conditions of the benchmark molecules: levonorgestrel and mifepristone )