Speedy Alternatives for Lengthy Government ApprovalsThu, 05/24/2018 - 11:00
Q: What led COFEPRIS to grant third-party authorizations for the agrochemical sector?
A: COFEPRIS does not have the capacity to satisfy the demands of the agrochemical industry. Some years ago, the pharmaceutical industry had the same problem so the council used authorized third parties to address the issue. This model has been successful in the pharma industry, particularly the verification units for drug products and medical devices. In only five years, they have provided over 10,000 new registrations. The pharma industry can now complete these registrations in only a few months. The agrochemical sector has been requesting this from COFEPRIS for two years and we expect to replicate the success this scheme has had in the pharmaceutical industry.
Q: How have you been received by the market and are two authorized third parties enough to cover demand?
A: Every two years, COFEPRIS launches an open call for new companies to participate as authorized third parties. COFEPRIS expected more companies to obtain the authorization but the truth is that the processes are very strict and rigorous. The authorization of two companies is not enough for the entire market but it is a first step. At AVS, we have four reviewers with different authorizations. For instance, all four experts oversee plant nutrients, three are authorized for a chemistry specialty and two for the toxicology specialty. Although we only have four reviewers at the moment, we can increase our number of reviewers to meet demand.
Despite being authorized by COFEPRIS, some companies are reluctant to use our services. Large companies that also have experience with third parties in the pharmaceutical industry have no problem working with us but the vast majority of companies are still waiting for the first round of proceedings to be completed before deciding whether to use our services.
Q: How do your services add value to the operations of pesticides or nutrients companies?
A: The goal is to shorten time frames. It takes up to 36 months to obtain a new registration but by using authorized third parties, any registration can be obtained in less than six months. This effort translates to prompt commercialization of products.
Companies need the capability to plan and map the market. They cannot do this because they do not know if their product’s registration will be ready on time. It is a matter of strategic planning. Mexico is the world’s 12th-largest food exporter but we expect that by 2050 the country will take a leap forward to become a Top 8 exporter. The only way to lower prices is to have more participants in the industry offering innovative products and generics. Many farmers use counterfeit goods because they cannot afford patented products. This new regulation will help spur both growth and the introduction of new products at more competitive prices, which means that farmers will have the capability to purchase registered products and generics. That will be beneficial for the agricultural sector overall.
Q: Between 2010 and 2017, COFEPRIS granted over 7,000 pesticide registrations. How will the introduction of authorized third parties impact future results?
A: The problem COFEPRIS faces is its capabilities. It has a significant backlog for new product registrations because it does not have the human resources to quickly review all the new applications.
We expect the number of registrations will increase because there will be more reviewers in charge of doing what COFEPRIS is doing now. There will be more products on the market and many producers of agrochemical products will be able to standardize their operations. I do not have an estimate regarding the magnitude of the growth that the industry will experience but I have no doubt that the industry and the number of reviewers will grow.
AVS is an authorized third party that focuses on agrochemical products for the Mexican market. The figure of authorized third parties, designated by COFEPRIS, for the agrochemical sector was announced in early 2018