5 tips of regulatory project management in ASEAN
During the expansion of territory in the traditional business model, there will be multiple distributors that manufacturers must deal with. Unlike big companies that have a dedicated staff looking after the region. Smaller companies or companies that do not have a local office established in the territory will rely on their business manager who might not be as well versed in regulatory as a “project manager.”
Sometimes it might lead to some miscommunication regarding the requirements since the meeting with the local companies would be limited hence it might be worth to consider having a regulatory project manager to oversee the local regulatory experts so to ensure alignment with regulatory goals and objectives set out by the headquarters.
Regulatory project management in TRC’s term is about managing data flow from the local experts to a centralized system where it is updated, accessible and reliable for the global headquarters to have visibility in terms of product licenses compliance.
Below are 5 tips to share on regulatory project management:
- Maintain and establish a good friendship with local regulatory experts.
This will play a big role when manufacturer would want to transfer the licenses back to their own name or switch distributor. Based on observation, relationship tend to sour during the announcement and the local regulatory personnel will play a critical role to mediate the whole situation.
- Establish clear timelines and achievable expectation in terms of market feedback.
Headquarters would roll out several variations decision consecutively expecting the local experts to provide an assessment on the risk, impact on the product line as well as the documentation requirements in a short notice which would not be feasible. At times, the variation that are to be executed might not fall into any appropriate MIVs / Change notification category and local experts will need time to verify with the authority before providing a decision. It would be worth to consider establishing a schedule of upcoming variations/change notification and implementation timeline for each product line for each quarter to share with appropriate partners.
- Conduct regular reconciliation of regulatory information regarding the product licenses with individual partners to align with what is captured in the system.
To do this appropriately, it would be good to have a 1 hour focused call weekly if necessary to run through all the information and questions if not a bi-weekly catch up to just check for any new updates or situations or support that might be required from the local regulatory partners.
- Always be ready to support and facilitate any miscommunication or requirements from both ends.
The regulatory project manager must digest then interpret the requirements from both ends and align the understanding with the local experts and headquarters before going to either party to clear the air.
- Prioritize the most critical issues to be addressed instead of bugging the local experts repeatedly to answer a question.
In the situation where there are several critical issues e.g., site change, change of supplier of excipients, minor update on labelling to reflect the new EC representative details, , the regulatory project manager will need to have visibility of each local market situation from both the regulatory and commercial front. This is to enable the regulatory project manager to strategize and rank the issues to be addressed first in terms of the impact on sales, compliance, and implementation so to advise the local regulatory partners appropriately.
Synergy in regulatory project management emphasizes heavily on being systematic, having clear understanding of the ground issues and maintain a good relationship with the local regulatory partners to ensure succession execution. TRC subscription plan would be able to facilitate this activity should you require support. Feel free to reach out if you need help or stay tuned for the next blog.