Main Aspects to Consider in Supporting Safety and Efficacy for the Sanitary Registration of Pharmaceutical Products in Peru

Q.F. Ronald Erik Quiñonez Dextre
Regulatory Affairs, Safety and Efficacy Analyst
SCR Consulting Peru

With the enactment of the Law No. 29459: “Law on Pharmaceutical Products,
Medical Devices and Health Products” in 2009; and subsequently with the approval
of the “Regulations for the Registration, Control and Sanitary Surveillance of
Pharmaceutical Products, Medical Devices and Health Products” (approved
through Supreme Decree No. 016-2011-SA) in 2011, new guidelines, standards, criteria
and basic requirements were established to ensure that pharmaceutical products,
medical devices and health products marketed in Peru are effective, safe and of high
quality. Furthermore, the principles of safety and efficacy are supported through
preclinical and clinical studies.
Among the multiple regulatory requirements stipulated by Peruvian regulations for the
sanitary registration of pharmaceutical products, as outlined in Supreme Decree No.
016-2011-SA, the submission of technical information or studies supporting the efficacy
and safety of the pharmaceutical specialty to be registered is paramount.

Prior to presenting the considerations that must be taken into account in substantiating
the safety and efficacy of pharmaceutical products, it is important to keep in mind the
following concepts, drawn from Law No. 29459:
One of the primary activities to be carried out when starting the revision of a dossier of
a pharmaceutical specialty is to identify to which category it belongs. In Peru, there are
three categories and taking this into account, it is possible to determine what information
must be submitted in order to support the safety and efficacy of the pharmaceutical
product to be registered. In order to provide a better detail to the above mentioned, the
following table is presented:

(Own authorship)

In general, in the absence of a pharmaceutical product equal to the one registered in
the PNUME, PAVS, EMA or WHO, the safety and efficacy support would be provided by
objective and prestigious reference literature such as the WHO formulary, British
National Formulary (BNF), Martindale, UpTodate, Cochrane, PubMed, among others;
through clinical studies, pragmatic studies, systematic reviews, observational studies,
epidemiological studies, bibliographic research and bibliometric studies, as appropriate,
of the API in the same pharmaceutical form, concentration/dose and route of
administration to be registered.
Other requirements that are related to the safety and efficacy of the product to be
registered are the Therapeutic equivalence studies to demonstrate the exchangeability
and Risk Management Plan. For the submission of the equivalence studies, the guidelines
described in Supreme Decree No. 024-2018-SA must be followed, in addition to
considering the lists of drugs to which the submission of these studies is required, which
are presented in Annex 1 and 2 of RM_404-2021/MINSA. For the preparation of the
Risk Management Plan, there is the Technical Health Standard No. 156-
MINSA/2019/DIGEMID and it is presented when the pharmaceutical product contains
an API that has not been previously registered in the country.
All the information that will be presented in order to support safety and efficacy will also
be included in two very important documents, leaflet and summary of product
characteristics, which are directed to the population and health professionals,
respectively. It is worth mentioning that the information in these documents must
correspond to the safety and efficacy information presented in the table above.
to be aware of safety alerts issued by the National Medicines Authority (DIGEMID), PAVS,
EMA or WHO, which may require compliance with certain provisions as part of safety and
efficacy reporting.
In conclusion, it is extremely important to be at the forefront of the updates in the
Peruvian regulations and in the new guidelines that are continuously being released by
the various countries with High Sanitary Surveillance Countries and Health Agencies in
the world, since they will allow us to ensure that the pharmaceutical product to be
marketed in Peru complies with the minimum requirements that support its safety and
efficacy, as well as its adequate access by the population.

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