Best Practices For Conducting Multinational Clinical Trials | Page 13

Table 4.

Marketing Application Process By Country

In Singapore, the NDA has three possible paths
for evaluation: a full dossier (product not
approved by any drug regulatory agency at
time of submission), abridged dossier (product
evaluated and approved by at least one drug
regulatory agency), or a verification dossier
(product evaluated and approved by at least two
of HSA’s reference drug regulatory agencies:
EMA, US FDA, Health Canada, Australia Federal
Goods Administration [TGA], or UK Medicines
and Healthcare Products Regulatory Agency
[MHRA] and meets other eligibility criteria).19
The application is submitted in two parts: PRISM
(online submission) and registration dossier,
which must be submitted within two working
days of the PRISM submission. A local agency
must complete the application, and proof of
GMP compliance is required. In addition, at
least six months’ accelerated stability data and
12 months’ real time stability data are required.
Separate applications are required for different
strengths/dosages.

*Includes clinical and scientific documentation of safety
† Certain categories of OTC products and traditional medicines

In South Korea, an approval application is
required for products requiring a safety and
efficacy review, while a notification application
can be completed for a product that is already
included in the Korean, US, Japanese, British,
German, and French Pharmacopeia and has
already o