Trust: The Essential Element When Working with RegulationsWed, 09/05/2018 - 10:04
Q: How has NYCE’s service portfolio evolved alongside the industry and regulators?
A: NYCE began operating as an authorized third party for healthcare in early 2011 but the company’s history dates back to 1994 with the certification of electronic products, including medical devices. Since then, we have incorporated six companies: NYCE Laboratorios, which is in charge of developing test protocols; CNCP, in charge of conformity concerning plastics, water and chemicals; NYCE SIGE, which certifies management systems and Movilar NYCE, which will oversee the evaluation of hydrocarbons. NYCE also has two companies abroad: NYCE Colombia and NYCE Asia. The company plans to continue growing and by 2018 our medicine division will expand to include biotechnological, allopathic and herbal medicines.
NYCE is greatly concerned with continuous improvement and is one of the few verification units with an ISO 9000 certification, which we have had for over 10 years. By early March 2018, NYCE had generated over 1,100 technical reports, of which over 90 percent have been approved. Our last audit by COFEPRIS awarded us a “highly trusted” rating. NYCE has also developed over 700 standards to support several sectors, including plastics, polymers and electronics, and we are collaborating with the government on the development of NOMs for the benefit of the industry.
Q: What is the next step in the collaboration between NYCE and COFEPRIS?
A: As the technical arm of COFEPRIS, NYCE is in a position to support both the industry and the regulator. Our role is to help COFEPRIS accelerate its processes to review and approve paperwork while ensuring compliance with all regulations. Authorized third parties are relatively young organizations, having been created only seven years ago, so the next step is to reinforce and consolidate them.
COFEPRIS is becoming increasingly open to authorized third parties, which have allowed the regulator to shorten its approval times and get rid of most of its backlog. COFEPRIS is also increasing the capacities of authorized third parties. For example, in early 2018 it opened tenders for authorized third parties for advertising and pesticides.
Q: How do the authorized third parties support COFEPRIS’ continuous improvement processes?
A: We have opened opportunities for the creation of technical appointments (citas técnicas) through our close collaboration with COFEPRIS. This has allowed a close communication to streamline approval processes and greatly reduce approval times, benefiting both the industry and COFEPRIS. This collaboration has allowed the reduction of registration times from over 73 days to less than 30 in the case of medical devices and from 54 to 28 in medicines, benefiting companies willing to import their products into the Mexican market.
Q: How are local regulators working to improve the pharmaceutical sector?
A: The Mexican government is involved in the generation of alliances and trade agreements with foreign countries but it must also invest in the strengthening of the Mexican industry. It would be extremely beneficial for local companies already certified by COFEPRIS to have such certifications recognized abroad. For example, having the quality of Mexico’s products recognized throughout Latin America would be a boost for the sector. Our regulators are making great efforts to obtain recognition from WHO and PAHO, which will help the local industry.
Q: What can Mexico offer so that foreign companies continue investing in the country?
A: Investments may slow slightly during 2018, as the sector awaits the course to be outlined by the new presidential administration. We have seen great interest from the foreign pharmaceutical sector to continue investing in Mexico as new medications enter the country every year. The pharmaceutical sector does significant investment in R&D, which translates into the development of innovative medications to treat common diseases.