Q&A for supplier reference

1. Exact fields that need to be captured from each of the websites as the information
presented.

J&J: This is what we are proposing, however this will depend on the information
available in the respective Health Authority websites and what are the search fields that
a service provider can accommodate. 

Pharmaceutical – New Registration

 Product name
 Generic Name (if available)
 Dosage form
 Route of administration
 Active Pharmaceutical Ingredient & Strength
 Indications
 Registration No.
 Registration Classification/ Pathway (if available) : Import generic, New Chemical Entity
(NCE)
 Product classification eg: OTC, Rx
 Drug Type (Chemical, TCM, etc)
 Manufacturer Name
 Manufacturer Address
 Local MAH Name
 ATC Class (if available)
 Therapeutic Class (Analgesic, Cough) (if available)
 Review Type (priority review/ urgent need) (if available)
 Date of submission (if available)
 Submission review status (if available)
 Approval Date (if available)
 HA Review Result (approve/reject) (if available)
 Reference List Drug (if available)
 Marketing status (if available) 

Pharmaceutical – Clinical Trial

 Study registration no.

 Generic Name (if available)
 Product Name
 Active Pharmaceutical Ingredient

Cosmetic – New notification/Registration

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 Registration Name (if available)
 Product name
 Company Name
 Company Address
 Registration No.
 Registration Classification
 Claimed Efficacy (if available)
 End user (if available)
 Manufacturer Name
 Sourcing country (if available)
 Ingredients (if available)
 Registration Date (if available)
 Registration Province (if available)
 Product Category (if available)
 Technical Review (if available)
 License status
 Product 2D picture (if available)
 Product 3D picture (if available) 

1. Expectations on the PDF description for TGA website

J&J : All information that is available in PDF may need to be provided based on our search
fields.

1. Do you need product images where available?

e.g. http://ftba.nmpa.gov.cn:8181/ftban/fw.jsp has a link for images

J&J: If possible we will prefer for the images to be made available, however if difficult or not
possible, please let us know.

1. Do you need translation of the Chinese content (to English)?

J&J: Yes we will require translation from Chinese to English.

1. Do you need all available historical data or just forward data?

J&J : Please advise if it’s possible to provide historical data as it may be important for data
trending.

1. Assuming there is a team that is currently/was doing this work manually - any major
lessons learned from that project? 

J&J : It was a very resource intensive process, however there weren’t any major hurdles.

 
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 1. Any restrictions on where data can be hosted/stored? 

J&J: We prefer the data to be hosted in J&J server.  

2. list of websites that JNJ consumer to track from. Please note that the list may not be
complete but will give you a good estimation of what we need and you may notice
that some of these info are from the same website but from a different webpage.

 China OTC

New Registration & Variation

http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html?type=yp

http://list.cde.org.cn/index/lists

http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3#

Filling

http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html?
CbSlDlH0=qGq2rGrd6vkDKrDVS_p1sftwGUAY8rXIwQAXE_sUuFgqqtQ

Clinical Trial

http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3#

http://www.chinadrugtrials.org.cn/

Reference Listed Drug & Post Market Surveillance

https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/index.html

 China Normal & Special Cosmetic

http://ftba.nmpa.gov.cn:8181/ftban/fw.jsp

http://cpnp.nmpa.gov.cn/province/webquery/list.jsp

http://app1.nmpa.gov.cn/data_nmpa/face3/base.jsp?
tableId=69&tableName=TABLE69&title=%E8%BF%9B%E5%8F%A3%E5%8C
%96%E5%A6%86%E5%93%81&bcId=124053679279972677481528707165&CbSlDlH0=qGckr
GrNFK2NFK2NF1xhci.Br9lb_29pRYb1ZokZI5GqqD9

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  Australia OTC

New Registration

https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg

 India OTC

New Registration - For Products registered locally. We can get the Generic name of product,
Strength and indications and date of approval.

https://cdscoonline.gov.in/CDSCO/Drugs  

 India Cosmetic/ Global Clinical Trial/ Medical Device

Registration information – For Applicant Company Name and Address, Cosmetic Category,
RC no., Name and Address of Foreign manufacturer, RC Validity etc.

https://cdscoonline.gov.in/CDSCO/Industry

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