Why is regulatory intelligence exercise crucial for pharma companies looking to expand into new territories ?

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Regulatory intelligence as  defined in TRC’s understanding is  market research on regulations with the following objectives in mind:

• To obtain the most accurate information concerning pathway , application type , requirements , timelines, and fees of the pharmaceutical or medical products to be registered
• Impact of a certain regulations on existing pipeline of products
• The feasibility of using existing dossier to apply for marketing authorization in the territory of interest
• Get a framework of how a certain product is regulated in a certain market as a global regulatory strategy
• To examine a potential question e.g a lack of certain documents such as not having PIC/S GMP or not meeting certain criteria e,g not having Zone IVb stability data which is essential in ASEAN countries or  not having prior approval  in reference agencies of the territory  could be critical for registration in the case of biosimilars

Conducting regulatory intelligence prior to a product launch or an annual exercise could have the following advantage:

• Anticipates the possible hurdles during registration which could be mitigated by working on the gaps based on the results obtained from the regulatory intelligence exercise
• Better understanding of whether it makes sense to enter the market despite a high volume potential e,g in the case of independent license holding in Indonesia for pharmaceutical products
• Get an affirmation of the accuracy of the data in the regulatory database for the product of interest
• Make calculated risk based decision to have an independent license holder or to engage a distributor in the territory of interest
• Be more informed and prepared in the case of meeting potential distributors or clients to discuss about collaboration in the territory of interest

TRC’s approach of conducting regulatory intelligence exercise is presented as per below:

• Understand the commercial and regulatory objectives of the exercise pertaining to the product interest
• Conduct relevant on the ground market research through local expertise and accumulative experience
• Performing a gap analysis exercise
• Presenting the outcome and recommendations to the Client so as to support their internal decision

TRC has launched a basic regulatory subscription plan which can be useful to support such regulatory initiatives  and feel free to share the article to those who might need this.

 

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