Amendments to the Official Mexican Standard NOM-059-SSA1-2015, which Regulates Good Manufacturing Practices

The purpose of this notice is to inform you that, on March 19th, the Ministry of Health published in the Official Gazette of the Federation amendments to the Official Mexican Standard NOM-059-SSA1-2015, which governs Good Manufacturing Practices for Drug Products. Below, we share the key points:

New Requirements for the Release of Biotechnological Drug Batches

Mandatory Analytical Certificate: Each batch must be accompanied by an analytical certificate issued by the manufacturer, certifying compliance with the quality control specifications established in the marketing authorization or sanitary registration.

Documentary Review or Laboratory Testing: For imported biotechnological drugs (excluding vaccines), each batch of the finished product must be approved by the qualified person prior to its release for commercialization. Such release may be carried out through a documentary review or laboratory testing.

Recognition of Foreign Certifications:

• Quality analyses may be conducted either in the manufacturer’s control laboratory or in a certified external laboratory.
• Certificates of Good Manufacturing Practices issued by the Ministry of Health or by international regulatory authorities that are members of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), or those included in the list of Transitional WHO Listed Authorities (WLAs) with a recognition level of B or D, will be recognized.
• Equivalence Agreements may also be applied, allowing foreign regulations to be accepted in Mexico, provided they meet equivalent standards.

Other Key Amendments to NOM-059-SSA1-2015

New Definitions Introduced:

• Biotechnological Drug: Therapeutic product obtained through molecular biotechnology.
• Equivalence Agreement: Recognition of foreign sanitary regulations in Mexico.

Update of Applicable Regulations: References to standards such as NOM-073-SSA1-2015 (drug stability), NOM-220-SSA1 2017 (pharmacovigilance) and NOM-164-SSA1-2015 (Good Manufacturing Practices) have been amended.

Regulatory Harmonization and Entry into Force

These amendments, which will enter into force on December 1st of the current year, aim to expedite the availability of biotechnological drugs in the country by aligning regulatory requirements with international standards and ensuring their safety, efficacy and quality.