This applies for local manufacturers only

For initial registration

Comparative Dissolution study data should be submitted according to the WHO guidelines for Comparative Dissolution or Biowaiver. The comparator for the dissolution study should be decided in consultation with the NMRA.

At the end of the Provisional Registration period, for conversion from provisional Registration to Full Registration.

1. BCS Class I & III excluding narrow therapeutic index and modified release a Biowaiver study report should be submitted according to the WHO Biowaiver guideline.
2. BCS Class II & IV, narrow therapeutic index and modified release drug products a bioequivalence study should be submitted for Full Registration.
3. If a Bioequivalence study is not available for products in point 2, a commitment letter with evidence will be accepted for continuation of Provisional Registration.

Rolling Provisional Registration is granted for a maximum of four year within which a Bioequivalence study data should be submitted.

‍