The Changing Regulatory Environment in Latin America – Focus on Good Review Practices

The emerging markets of Latin America (LATAM) are becoming increasingly important to pharmaceutical companies in their strategies for global registration of new medicines and making them available to patients.

In view of the challenges and changes occurring within the Latin American agencies, and also recognising that measuring the regulatory environment helps both companies in planning their strategy and agencies in managing review process expectations, the Centre for Innovation in Regulatory Science (CIRS) has recently released R&D Briefing 58 entitled “The changing regulatory environment in Latin America; Focus on Good Review Practice”.

This Briefing is intended as a background document to encourage discussion among and between regulatory agencies and companies of the key issues, and to explore further improvements in the LATAM regulatory landscape.

The Key points from the Briefing are as follows:

REGIONAL ALIGNMENT (FIGURE 1)

Country-specific challenges to pharmaceutical companies looking to enter the LATAM region remain and many of these stem from a wide spectrum of regulatory philosophies, review practices and other policies as well as procedural issues. Building trust and confidence should be encouraged and LATAM countries should continue aligning their activities regionally and reinforcing harmonisation initiatives.

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FACILITATING THE REVIEW (FIGURE 2)

Factors such as better communication and increased agency-industry interactions and collaborations will result in increased knowledge, capacity and expertise and could lead to a more efficient and timely review process.

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ELEMENTS OF GOOD-QUALITY REVIEW (FIGURE 3)

As agencies in LATAM develop their processes and practises, it is important that they also build quality into the process and continue to embed widely documented good review practices (GRevP). Within the agencies, these practices will promote not just timeliness, but also process predictability, consistency, transparency and high quality across both the review and management of the process.

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The full report is available for download with more insights into the LATAM regulatory landscape:

  • Changes in the regulatory review times
  • Extent to which good review practices are embedded in the agencies
  • Recommendations and the learnings from the 2014 CIRS Workshop in Lima
  • Recent 2015 observations and insights from agencies and multinational companies based in Colombia, Brazil and Mexico

Download the report here >>

CIRS – The Centre for Innovation in Regulatory Science – is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters.