Overview:
On October 30 2020, Mexico’s Health Authority, COFEPRIS, modifies the pharmacovigilance regulation, NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.
The most important modifications to the regulation include: A change in EA, SRAM, RAM and ESAVI notification times; The only RPS to be sent to the CVF are for new molecules, orphan drugs and when request of the health authority based on a safety concern; PMR must be developed when a new molecule is registered in the country or granted a orphan drug denomination for the first time.
2016 Regulation Vs. 2020 regulation
List of requirements | Before change (before Oct 2020) | New regulation ( Oct 2020) |
EA, SRAM and RAM notification times | § Serious: 7 naturals days § Not serious: 90 naturals days § Two serious or more similar cases in the same place with the same drug and the same batch. Immediately without exceeding 48 hours. § Ineffectiveness: 15 naturals days § Notification of scientific literature: 30 naturals days | § Serious: 7 naturals days (Lethal) and 15 naturals days (no lethals) § Not serious: 90 naturals days § Two serious or more similar cases in the same place with the same drug and the same batch. Immediately without exceeding 48 hours. § Notification of scientific literature: 30 naturals days |
ESAVI notification times | § Serious: Immediately without exceeding 48 hours § Not serious: 15 naturals days § Two serious or more similar cases in the same place with the same vaccine and the same batch. Immediately without exceeding 48 hours. § Ineffectiveness: 15 naturals days § Notification of scientific literature: 30 naturals days. | § Serious: 7 naturals days (Lethal) and 15 naturals days (not lethal) § Not serious: 30 naturals days § Two serious or more similar cases in the same place with the same vaccine and the same batch. Immediately without exceeding 48 hours. § Notification of scientific literature: 30 naturals days
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RPS | § 8.2.1 RPS shall be developed for all authorized drugs and vaccines. § 8.2.2 RPS shall be submitted for each Health Registration in the format established by the CNFV in the “Pharmacovigilance Guide for the elaboration of the SRP”, published by the CNFV | § 8.2.2 The CNFV must receive the RPS of the medicines or vaccines authorized in Mexico in the following situations: § 8.2.2.1 New molecules, and § 8.2.2.2 At the request of the health authority based on a safety concern or issue from security. § 8.2.7.3 Orphan drugs will only submit the RPS to the CNFV during the first 5years, following the first award in Mexico of the profession of medicine recognition orphan. |
PMR development | § 7.4.2.2 Develop and send PMRs to CNFV for approval and assignment of coding. § 8.4 PRM § 8.4.1 Develop or update a PMR for medicines and vaccines when § 8.4.1.1 A drug or vaccine is registered in the country. § 8.4.1.2 A request is made to extend the health registration of a drug or vaccine in the country (applies to drugs and vaccines that have not submitted a PRM prior to the extension). § 8.4.1.3 A request is made to extend the health registration of a drug or vaccine in the country where there is evidence of a national or international safety concern or issue affecting the benefit-risk balance. § 8.4.1.4 For orphan drug | § 7.4.2.2 Is revoked § 8.4.1 Develop a PMR for medicines and vaccines when: § 8.4.1.1 A new molecule is registered in the country. § 8.4.1.2 It is revoked § 8.4.1.3 It is revoked § 8.4.1.4 Recognition as an orphan drug is granted for the first time in the country. § 8.4.1.7 It is derogated. § 8.4.2.2 It is revoked. § 8.4.2.5 Repealed. |
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