Authorized Third Parties Ease Registration Backlog

All drugs sold in Mexico must be tested by COFEPRIS, which led to a backlog that has since been solved by the creation of authorized third parties. This has helped the regulatory authority speed up processes and clear the bottleneck for new products

Only a few years ago, it could take up to two years for a company to register a new drug product in Mexico. Today, that wait time has been reduced to 20 business days. Behind this turnaround is a decision by COFEPRIS to allow private parties to do the leg work and put products on a fast track to approval. These private parties, known as authorized third parties (ATPs), perform testing and grant acceptance of a certain category of product, although the regulatory agency does reserve the right to reverse any decision an ATP makes.

“As an authorized third party, we help companies when they need regulatory advice; we become their channel to register new drugs. We do the clinical research that companies need to show COFEPRIS their products are safe and efficient and we are also in charge of dissolution profiles, clinical phases, protocol creation and analytical methodology,” says Héctor Ávila, Director General of Cecyc Pharma, an authorized third-party in Mexico City that specializes in bioequivalence testing.

The appearance of ATPs has helped to clear the backlog of pending authorizations. Products are now registered much faster, albeit with the same level of security and testing before being allowed onto the market. The system has been widely praised by industry insiders. “Speeding up processes through authorized third parties helped make the regulatory procedures more efficient and thus increased the attractiveness of Mexico as an investment destination for health,” says Geraldine Rangel, Director General of Healthlinks, a Mexican firm that provides market analysis to companies wishing to enter Mexico.

Between 2005 and 2014, US$1.7 billion was invested in Mexico in the medical devices sector, mostly in Guadalajara, Tijuana, Nuevo Laredo and Matamoros, according to ProMéxico. Investment in the pharmaceutical sector in the same period almost doubled that at US$3.2 billion, according to government figures, and in January 2017, COFEPRIS signed an agreement with industry players hoping to boost investment in clinical research from under US$200 million to US$600 million per year in the next two years.

According to a COFEPRIS 2014 press release, ATPs had reduced authorization wait times from an average of two years to 20 business days. “The creation of the authorized third-party system was a great decision. The fact that the government accepted that its internal structure could not deal with the volume of demand was a good move,” says Carlos Pérez, Director General of NYCE, an authorized third party that works across sectors.

To become an ATP, there must be no conflict of interest, the lab must have the technical, human, financial and infrastructure capacity to carry out its function and comply with the respective norms of the three classifications of ATPs: testing laboratories (NMX-EC-17025-IMNC-2006), units of interchangeability and bio-comparability (NOM177-SSA1-1998), and verification units (NMX-EC-17020- IMNC-2000). As of May 2017, there are 122 authorized testing laboratories, 62 units of interchangeability and biocomparability and 26 verification units. Each authorization is valid for a period of two years and must then be renewed, ensuring standards are kept. In the first five months of 2017, four ATPs lost their status, which can be regained once conditions are met again.

But challenges remain. As science and medicine advance, regulation sometimes struggles to keep up. “The biggest challenge is when COFEPRIS regulation does not specify which study should be undertaken for a certain drug. That is where we intervene and propose which study should be undertaken to obtain registration,” says Mezly Rodríguez, Operations and Strategy Director at Cecyc Pharma.

The next step, many hope, is for other countries to recognize Mexico’s authorized third parties to improve exporting conditions to Central and South America. “Hypothetically speaking, if COFEPRIS closes an agreement with the regulatory authorities of the Pacific Alliance countries, authorized third parties would be able to provide services to the whole region,” says NYCE’s Pérez.