Cofepris | Mexico | Regulatory | global regulatory partners

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

 

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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