Commercialisation of healthcare: Country Q&A Tool

Search the Country Q&A in the Commercialisation of Healthcare Global Guide by question and jurisdiction.

Step 1: Check the boxes to select the questions and the jurisdictions for comparison.
Step 2: Click the "submit" button.
Step 3: Scroll down to view answers and check law stated dates for each jurisdiction.

Choose your questions - Select all/De-select all

Choose your jurisdictions - Select all/De-select all

Regulatory overview

1. What is the regulatory framework for medical products?
 
2. What types of medical products are regulated?
 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?
 
4. Are there different requirements for patented and generic drugs?
 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?
 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?
 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?
 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?
 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?
 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?
 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?
 
12. Is it possible to sell devices to or buy devices from other jurisdictions?
 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?
 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?
 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?
 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?
 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?
 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?
 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?
 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?
 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?
 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?
 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?
 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?
 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?
 
{ "siteName" : "PLC", "objType" : "PLC_Doc_C", "objID" : "1248245965327", "objName" : "Commercialisation of healthcare Country QA Tool", "userID" : "2", "objUrl" : "http://us.practicallaw.com/cs/Satellite/us/resource/1-619-0437?null", "pageType" : "Resource", "academicUserID" : "", "contentAccessed" : "true", "analyticsPermCookie" : "22e97be00:15b0af9e485:3da7", "analyticsSessionCookie" : "22e97be00:15b0af9e485:3da8", "statisticSensorPath" : "http://analytics.practicallaw.com/sensor/statistic" }