By: Andrea Castillo
As of March 2023, it is published that Technical Standard 82 version 1-2023, on Bioequivalence and Therapeutic Equivalence of Drugs for Human Use, is under construction.
Background
The first time that the construction of Technical Standard 82 was published on the Ministry of Health website was in August 2020, with version 1-2020. It was proposed and evaluated before a Technical Board on two occasions, in August and October 2021 respectively. However, of the 8 Articles contained in this version, only point 5.3 was revised.
In 2023, version 1-2023 was proposed, which was presented to associations, guilds, professional associations, chambers and some users in general in March of the same year. The objective of the Standard remains the same, being to establish the requirements to demonstrate the bioequivalence and therapeutic equivalence of multi-origin drugs in order to guarantee their safety, quality and efficacy.
Updates
- This Technical Standard would have as its scope of application all multi-source drugs manufactured in Guatemalan territory and for those imported by natural or legal persons.
- The Prioritized List is established, where Active Ingredients are numbered and classified by sanitary risk criteria, which must comply with the provisions contained in this Technical Standard. It indicates the type of test to be submitted (in vivo or in vitro) and the reference product to perform the evaluations. This list will be updated every 3 years, with the support of the Multisectorial Technical Committee.
- The holders/manufacturers of pharmaceutical products subject to demonstration of therapeutic equivalence may perform the studies in Analysis Laboratories authorized by the National Regulatory Authority. This list will be published on the official website of the Department of Regulation and Control of Pharmaceutical and Related Products.
- It is indicated that a document authorizing the therapeutic equivalence and interchangeability of a product, issued by the Regulatory Authority of the country of origin, will be accepted.
Validity and transition
The Technical Standard will come into force one (1) year after its publication on the web page of the Department of Regulation and Control of Pharmaceutical and Related Products. It should be noted that the Standard is still under construction and is subject to change.
However, a transitional period will be granted for the corresponding products that do not have interchangeability studies at the time of entry into force. The option that most benefits the users will be applied, between presenting the studies at the moment of renewing the Sanitary Registration, or in a period of 5 years.