Background on Jorge Tanaka and His Relevance
Jorge Tanaka, the Director of Clinical Research at the Mexican Association of Pharmaceutical Research Industries (AMIIF), is a key figure in advocating for improvements in Mexico’s clinical research landscape. His insights are crucial as he aims to modernize and strengthen the country’s regulatory framework, which has been lagging behind neighboring countries like Argentina and Brazil.
Current Situation and Challenges
Mexico currently attracts around 200 million dollars annually in clinical research, but lengthy protocol approval times (up to 12 months) have hindered its competitiveness. In contrast, countries like Argentina approve protocols in just 45 to 50 days, making them more attractive for investment.
Tanaka’s Vision and Proposed Solutions
According to Tanaka, Mexico can regain its position as a leader in clinical research in Latin America and tenfold its annual investment within two to three years by streamlining regulatory processes. He emphasizes the need for modernized and robust Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to achieve this goal.
Regulatory Changes and Timeline
Tanaka highlighted that Cofepris has shown willingness to implement administrative simplification agreements and protocol approval equivalence, which could reduce approval times to 40 or 45 days. These changes are set to take effect by late May or early June 2025, aiming to expedite processes without compromising patient safety.
Economic and Scientific Potential
Mexico conducts around 500 clinical research protocols annually, a number Tanaka hopes to increase tenfold in the coming years. He acknowledges that Argentina has surpassed Mexico recently, with Brazil leading in protocol numbers and investment.
- Key Therapeutic Areas: Tanaka believes Mexico has significant potential in therapeutic areas such as obesity, cardiovascular diseases, oncology, and rare disease treatments.
- Economic Impact: Clinical research generates a 1.64 peso return for every invested peso and creates four indirect jobs for each direct clinical research position.
Importance of Clinical Research
Tanaka stressed the significance of clinical research in developing new medications and therapies that enhance the quality of life for millions worldwide. He also noted that it represents a strategic investment by the pharmaceutical industry, with an average annual investment of 30% of sales globally, totaling over 140 billion dollars.
Developing a new medication is a complex process, taking between 10 to 15 years from identifying promising molecules to market availability. Tanaka emphasized that ensuring treatment safety for patients is just as important as demonstrating efficacy.
Key Questions and Answers
- Q: What is the current investment in clinical research in Mexico? A: Mexico currently attracts approximately 200 million dollars annually in clinical research.
- Q: Why is Mexico lagging behind in clinical research compared to Argentina and Brazil? A: Mexico faces challenges due to lengthy protocol approval times, which can take up to 12 months.
- Q: What changes are being implemented to improve Mexico’s clinical research landscape? A: Cofepris is working on administrative simplification agreements and protocol approval equivalence to reduce approval times.
- Q: What therapeutic areas does Mexico have potential in? A: Mexico has significant potential in obesity, cardiovascular diseases, oncology, and rare disease treatments.
- Q: How does clinical research impact the economy? A: For every direct job in clinical research, four indirect jobs are created, facilitating faster access to innovative therapies in public and private sectors.
