How to review and plan for the next regulatory cycle of activities


It has come to the end of the year where budgeting and planning are in full force for 2024.  In regulatory, we do it via the RPA way which stands for Review, Plan and Act .

TRC shall share a short summary on what RPA means :

Review

  1. Start off with product annual review to check for gaps and alignment with global database.
  2. Align the schedule and activities with headquarters for the upcoming year so that you can roll out the relevant schedule and communication plan.
  3. Prepare communication plan or schedule of upcoming variations and new product registrations for each specific market and inform respective partners of the timeline and what to expect. This is an important exercise to also get input on any new regulatory requirements that might be happening within the local market.
  4. Identify key areas to work on internally as well as with respective local partners.

Plan

  1. Align the regulatory launch plan with commercial launch plan and obtain consensus on priorities of the variations and new product launches.
  2. Budget the amount required for respective expenditures to partners, authorities, operating expenses ,travel expenses, any pass-through costs involving translation work if applicable .
  3. Plan for face to face meeting and annual audit with respective partners as part of due diligence and to maintain the good rapport between yourself and them if applicable.
  4. Ensure that consensus on activities and budget are obtained and accurate till date.

Act

  1. Hold meeting with internal and external stakeholders to confirm the plan.
  2. Adjust the plan and schedule accordingly after meeting to ensure alignment to concerned parties’ inputs.
  3. Prepare the respective packages for each product that is specific to each market.
  4. Execute the plan accordingly to schedule and be ready to support when issues arise.

We hope the above short sharing is interesting for your read. If you need support for your regulatory activities in the coming year in Singapore, feel free to get in touch.

 

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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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