Mexico accepted as ICH member - PLG LATAM Hub

­­COFEPRIS as a member of the ICH

The Mexican agency, COFEPRIS, received the approval of its membership in November 2021 at the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use, better known as ICH. Prior to this Brazil was the only Latin American country in the ICH, and Mexico is the first Spanish-speaking nation to join.

COFEPRIS already followed ICH guidelines for some parts of the submission dossier. However, it is expected that becoming a member of the ICH will further strengthen the regulation of pharmaceutical products and clinical research throughout the region, which will facilitate earlier and more equitable access to innovative therapies.

Some recent advances in the legislation include the acceptance of submission dossiers in English, the possibility of electronic submission for several procedures and significant simplification of requirements, such as for renewal of medicines registration.

Authorized Third Party (“Tercero autorizado”, also known as “Unidades de Predictamen”)

An authorized third party is a private consulting company that has been trained and accredited by COFEPRIS. A third party can be hired by the Applicant company to perform a pre-evaluation of the dossier before it is submitted to COFEPRIS. The list of authorized third parties are available on the COFEPRIS website.

All types of submissions are eligible for a pre-evaluation by authorized third party, including the initial marketing authorization application (MAA), variations, renewals for medicines and medical devices, and advertising materials. The company should send the completed dossier to the third party who will perform a gap analysis and request any missing information or changes in the documentation that are required.

When the dossier is deemed complete and evaluation is finished, the third party locks the dossier (i.e. it can be no longer modified by the applicant). A technical report with a positive opinion for submissions is issued. The sealed package and report can then be submitted by the applicant to COFEPRIS for evaluation.

This system was originally implemented in June 2012 to reduce timelines for approval. COFEPRIS. which would rely on the positive opinion issued by the third party and only perform partial evaluation of dossier when considered necessary. However, since 2018, COFEPRIS has been moving their internal processes towards full re-evaluation of submitted dossiers. Timelines for evaluation of dossiers that had passed through authorized third parties have been extended and now we can see no difference in timelines when compared to dossiers that are submitted directly to COFEPRIS.

Although some pharmaceutical companies still use authorized third parties, their services are now similar to those offered by consultancy companies such as PLG. Thus, we are able to facilitate preparation of a more complete dossier, potentially avoiding or reducing deficiencies in documentation and expedite approval in a shorter timeframe.

New Molecules Committee (“Comité de Moléculas Nuevas [CMN])

This Committee was formed in 2008 and comprises a member of COFEPRIS, the Health Secretary and invited members from medical societies, universities and other organizations, as well as key opinion leaders with known expertise in a specific domain.

The CMN has two sub-committees: the sub-committee for evaluation of biotechnological products and the sub-committee for evaluation of new medicines in development.

The CMN evaluates both new molecular entities and products that are new to the Mexican market:

• products registered in other countries, but not yet available in Mexico,
• new fixed-combinations
• new therapeutic indication for an existing product

For the approval of a new therapeutic option, an applicant should submit a product dossier to the CMN. This dossier will pass by a preliminary evaluation, and if approved, the CMN will set a date for a presential meeting with the company’s representatives.

During the meeting, the applicant will present summary information, with emphasis on the clinical, non-clinical and safety (risk management plan). After the meeting, the members of the committee may ask for further clarifications. The technical opinion is issued to the applicant, which main contain recommendations of additional studies or data that should be included in the submission dossier.

If the new therapeutic option already has the approval from a recognized health agency, the CMN may issue a special technical opinion without a meeting. Authorities recognized by COFEPRIS include the US Food and Drug Administration, Health Canada, Swiss Agency for Therapeutic Products, The Australian Goods Therapeutic Administration and European Medicines Agency.

Once the technical opinion, or special technical opinion, is received the company is authorized to submit the MAA to COFEPRIS.

The timeline for obtaining marketing authorization in Mexico is approximately 16.5 months. This includes an estimated 90 business days for the CMN process plus another 12 months for the COFEPRIS evaluation of the applicant’s dossier.

In case no meeting is needed, obtaining the Special Technical Approval may take 4 – 5 months.

These timelines are slightly longer than those foreseen in the Mexican regulation.

In addition, if no meeting is required it may be reduced to 75 business days for the CMN (60 + 15 days). For a Special Technical Approval, legislation highlights that this may take 20 business days, however typically this takes 4 – 5 months.

Retesting

After obtaining marketing authorization in Mexico, the local retest is mandatory for each importation before releasing the product into the market. This quality control analysis should be performed by the laboratory with license of the local legal representative or by a certified external laboratory in Mexico, where the transfer of analytical methods is needed. PLG can support companies with the analytical transfer process and help in finding a certified laboratory.

Local PLG Regulatory Team

Product Life Group (PLG) has a team of regulatory experts in the Latin American region. Our team has extensive technical knowledge, a deep understanding of the relevant legislation and local market insights. The local experts are complemented by teams in Europe who can support companies  usually  aligned to European regulations in understanding local requirements.