Steps to incorporate new regulation changes in approved marketing authorization (MAs)
Part of our routine activity in regulatory affairs is to stay in touch with the latest updates and happenings with our local authority so that we can interpret the new changes, assess the impact it has on our existing product licenses and implement a strategic plan to incorporate the changes. Today TRC would like to share the key steps in a typical internal regulatory assessment of new regulations changes:
- Understand the regulations thoroughly
Ensure that you obtain the latest draft or correct version of the new regulations and read the context in dept. Compare it with the current regulations and make notes on the differences that could be important for you to bridge the gaps.
When the draft guidelines are issued for consultation, ask all the questions that you have in mind to align your own understanding and to clear any doubts regarding the new changes.
If there are training sessions conducted by the authority prior to the implementation, it will be good to participate so as to refresh your memory and to enhance the understanding and learn about any new concerns during the Q and A session from other participants.
- Perform an internal assessment
Determine the BU (business unit) and product line that will be affected by the new regulations. Obtain the status of the marketing authorization and a brief understanding of the commercial status of the product in the territory involved.
Perform a gap analysis and document the gaps in order to bridge and incorporate the new change. This should be documented as concise and to the critical point as possible. Share the internal assessment document with the appropriate business unit to obtain feedback so that you can align the findings that you have identified during the gap analysis.
- Determine the steps to incorporate the change
Using the internal assessment as a guideline, prioritize changes in terms of criticality, the commercial impact on the product line and the resources available to support the implementation. Draw up a plan to strategize the implementation and align with local stakeholders and business unit on the requirements and timeline.
Monitor the process of implementation and review post implementation for areas of improvement and effectiveness as well as to capture any areas that were missed out during the initial phase of implementation.
Although the above steps are simple , there may be a risk of miscommunication and lack of internal resources when simultaneous of such regulatory changes are implemented, it could be useful to consider an additional experienced local support . If you think that TRC could be of help to you , please get in touch or learn more about how TRC subscription plan can facilitate the process.