Regulatory Challenges in Emerging Pharma Markets: Strategies for Success
Hareshh Ratwani
Independent Director I Advanced Corporate Strategy – IIMB I Pharmapreneur I Startup Founder & Director I Co-Founder I Startup Mentor | Corporate Governance Compliance I SBU Head – Emerging Markets |
The pharmaceutical terrain is expanding into emerging markets, presenting both exciting opportunities and unique challenges. The common frustrations, desires, and fears often encountered by companies when entering into these untapped potential grounds.
Let’s explore some of the strategies to overcome these challenges.
Today we talk of Regulatory Challenges
The biggest source of frustration is the ever-evolving and complex regulatory frameworks in emerging pharma market accompanied by the fear of intellectual property loss in diverse markets. Every company is desirous of efficient and streamlined regulatory processes for smoother market entry.
1.?????? Stay abreast of regulatory changes, invest in local expertise and establish proactive relationships with regulatory authorities. A dedicated regulatory affairs team can play an important role in navigating these challenges.
2.?????? Do internal regulatory reforms and for that collaborate with industry associations to influence positive changes and invest in technology that supports compliance. Engaging in open communication with regulatory authorities can foster a more efficient approval process.
3.?????? Prioritize robust intellectual property protection measures, conduct thorough due diligence when forming partnerships, monitor and enforce IP rights diligently. Implementing confidentiality agreements and trade secret protections can mitigate this fear.
Have you ever ventured into the exciting world of emerging pharma markets? What challenges did you face with the regulations? Pl share your experiences and tips