Changes with the potential to impact Module 3 of the CTD require careful and thorough assessment to determine the appropriate course of action. The change control evaluation of MAA must include a full understanding of the change, visibility of all impacted products (i.e., finished products and APIs), and must determine all countries where those products are registered. This might also include countries where a new product submission or approval is pending.
As registered details for a product can differ between countries, it is essential to review all variants of the relevant registered information so that a complete change control impact assessment can be performed considering the European countries regulations and guidelines. The assessment will determine the classification of the change and the required supporting documentation. Strategies for submission of change applications can be impacted by many factors, including expected approval timelines and the data requirements for submission.
A robust change control impact assessment of generic medicines is critical in developing a suitable MAA change submission strategy, and for ensuring continued product compliance. Freyr’s CMC Regulatory affairs team has extensive knowledge and experience in pharma change control assessment/change control impact assessment, preparation of change-related submission packages and developing generic medicine change submission strategies in alignment with Health Authority requirements and guidelines.
Pharma change control impact assessment for all dosage forms in all countries in accordance with relevant regulations and guidelines
Preparation of a relevant MAA change submission strategy
Preparation of supporting Regulatory documentation (e.g., revised Module 3 sections, Module 1 documentation) and compilation of submission packages for finished products and APIs
Regulatory consulting on generic medicine change submission strategy of proposed changes
Managing Health Authority interactions (submissions, HA questions)