New Drug Product is defined by NPRA as any pharmaceutical products that have not been previously registered in Malaysia in accordance with the provisions of the CDCR 1984
It is further classified as below
- New Chemical Entity (NCE) – single/combination product with an active substance never registered with DCA (Drug Control Authority) Malaysia before
- Hybrid (single/ combination products with registered active moieties) – all other products registrable that does not fall under NCE subcategory
The difference between both subcategories would be the document requirements and timeline for registration. NCE subcategory requires a longer evaluation period, more clinical/Nonclinical documents and even consultation with local Malaysian clinical specialists.
There are situations such as a global innovator is not present/registered before in Malaysia. However, a global generic product of it to be registered in Malaysia. This would not follow the classic Generic registration route as it would be deemed as a New Drug Product Hybrid registration route in Malaysia. A “first of its kind” in Malaysia.
We have vast experience in this registration route for many therapeutic categories. Contact us for more information and a competitive quote !
