Karen M, one of our Switzerland-based consultants, recently shared her insights into emerging markets with us. Here are Karen’s five tips to consider before sending your product to a new or developing market:
- Understand existing regulations
- Regulations may vary from country to country
- When using the Common Technical document (CTD) format, be sure to address the country specific requirements in Module 1
- Regulations vary for the type of product (i.e. new molecular entity, generic, biosimilar, medical devices, vaccines, etc.)
- Understand the WHO Certification on the Quality of Pharmaceutical Products Moving in International Commerce (CPP Scheme)
- From which countries will CPPs be accepted for registration?
- What is the cost?
- What is the validity?
- Understand the approval process
- The time frame can vary from country to country
- Is it necessary to have an agent or other authorized person present in the country to interact with the regulatory authorities?
- Understand the competition and need for marketing as well as pricing and distribution practices
- Is there a medical need for this product to be marketed?
- How will this product be priced?
- Is there an adequate distribution network?
- Understand the business aspects as well as the regulatory aspects
- How will the product be advertised/promoted?
- Who will market the product in a particular country and is there an adequate sales force?
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RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.
