Life Sciences Newsletter – December 2020



Seroprevalence: The National Center of Epidemiology, Prevention and Disease Control published on its website the progress of the seroprevalence study for COVID-19 in Peru:

The seroprevalence study in Metropolitan Lima and Callao, at 100%, points out the following results: the prevalence of antibodies is 39.3%; women show more prevalence of antibodies than men; children and adolescents have greater prevalence (41.1%) than the other age groups; the high socio-economic status has the lowest prevalence (13.1%) and the medium under the highest prevalence (52.8%).

Click aquí to access the progress of the seroprevalence study in Peru.

Click aquí to access the seroprevalence study in Lima and Callao.

Epidemiological Alerts: In December 2020, the National Center for Epidemiology, Prevention and Disease Control issued two epidemiological alerts:

Alert No. 29 (AE-CDC-No.029-2020) on strengthening community epidemiological surveillance for the timely identification and follow-up of cases of COVID-19. Two actions are established: 1) Control of community transmission; 2) Timely detection of cases through early diagnosis of secondary symptomatic cases and timely diagnosis of asymptomatic and pre-symptomatic cases.

In addition, there is a flow chart for the surveillance of COVID-19 cases from the uptake of people with respiratory symptoms until the confirmation of the case.

Click aquí to access Alert No. 29.

Alert No. 30 (AE-CDC-No. 030-2020) on the risk of increasing the number of COVID-19 cases and hospitalized for massive assistance in markets and shopping centers before the celebration of Christmas and New Year holidays.

Click aquí to access Alert No. 30

Molecular tests: The National Institute of Health reported that there are 76 laboratories nationwide, between public and private, for the molecular detection of SARS-COV-2. 29% are private laboratories, 46% are located in Lima and the regions of Ancash and Huancavelica do not yet have molecular laboratories.

Click aquí to access the information.


Exceptional authorizations for health emergency: Digemid granted 370 exceptional authorizations to pharmaceutical products. The products with the most exceptional authorizations are: medical oxygen, azithromycin 500mg tablets, ivermectin 6mg/ml oral solution and paracetamol 500mg tablets. Only one biological product has exceptional authorization: tocilizumab under the trade name of Actemra.

Click aquí to access the publication

In addition, Digemid granted 801 exceptional authorizations to medical devices comprising 615 rapid tests, 184 molecular tests, 1 molecular rapid, and 1 sampling tube.

Click aquí to access the publication

Rapid test evaluation: Digemid published the list of rapid tests that were evaluated in their performance values, specificity and sensitivity to both IgG, IgM and IgG/IgM. The evaluated rapid tests have exceptional authorization, health registration and health registration certificate.

Click aquí to access the list.

Interchangeability: the regulation that regulates interchangeability established that for products containing cyclosporine and sodium mycophenolate, reports of results of comparability tests must be submitted until March 2021. Below, we detail the progress of interchangeability in Peru:

– Four pharmaceutical products have shown to be interchangeable.

– Only one of them (Cyclosporine) is mandatory. The other three belong to voluntary applications.

– 205 voluntary applications have a directorial resolution authorizing the reference product to be used as a comparator in conducting therapeutic equivalence studies.

Click aquí to access the list of products that showed interchangeability.

Click aquí to access the directorial resolutions authorizing reference products.


Cannabis was removed from the UN List IV: on 2 December 2020, the United Nations (UN) Commission on Narcotic Drugs removed cannabis and cannabis resin from List IV of the 1961 Convention.

The World Health Organization (WHO) Committee of Experts on Drug Dependence made recommendations to remove cannabis and cannabis resin from List IV of the 1961 Convention. The recommendation was based on information indicating that the cannabis plant and resin are not particularly likely to produce harmful effects similar to those caused by the other substances in List IV of the 1961 Single Convention on Narcotic Drugs.

In addition, the request was supported by data showing that cannabis preparations relieve pain and other symptoms such as epilepsy and spasticity associated with multiple sclerosis.

Click aquí to access the UN Commission on Narcotic Drugs press release

Establishments with license for import and/or commercialization of medicinal cannabis and its derivatives: Digemid published a list with more than 50 pharmaceutical establishments (drugstores, pharmacies and apothecaries) that have licenses for the import and/or commercialization of medicinal cannabis and its derivatives.

Click clic to see the release.


Certificate of Good Manufacturing Practices (GMP): Supreme Decree No. 036-2020-SA extends for one year the validity of GMP certificates of foreign pharmaceutical product laboratories issued by Digemid that expired during the national health emergency. Likewise, GMP certificates issued by high health surveillance countries and by the authority of the country of origin or their equivalents whose validity expires between March 11, 2020 and December 30, 2021 shall be accepted until December 31, 2021, provided that the foreign authority is extended.

In the case of medical devices, GMP certificates or documents proving compliance with Quality Standards issued by the authority of the country of origin shall be accepted, whose validity expires between March 11, 2020 and December 30, 2021.

Click aquí here to access the Supreme Decree

Telehealth: Ministerial Resolution No.1010-2020/MINSA adopted the document National Telehealth Plan of Peru 2020-2023, with the aim of improving the population’s access to health services in Peru. The main objectives include the following: to promote the improvement of the conditions in which Telehealth services operate, to establish financial mechanisms and incentives that contribute to telehealth, to promote initiatives and strategies that facilitate the implementation of telemedicine, telemanagement, teletraining and teleinformation, education and communication services.

Click aquí to access the National Telehealth Plan

In addition, Ministerial Resolution No.1074-2020/MINSA adopted the draft regulations of the Framework Law of Telehealth and the Legislative Decree that strengthens the scope of Telehealth, Law No. 30421 and Legislative Decree No.1490, respectively.

Click aquí to access the draft.

Pharmacovigilance: Ministerial Resolution No.1053-2020/MINSA adopted the technical document: Manual of Good Pharmacovigilance Practices, applicable to drugstores, laboratories and specialized stores that distribute, store, manufacture and/or commercialize pharmaceutical products.

The document contains considerations for establishments that are and are not holders of health records and certificates of health records referred to the quality assurance system, infrastructure and equipment, personnel, standard operating procedures, management of suspected adverse reactions, among others.

A national pharmacovigilance officer is required to report to the Digemid.

Click aquí to access the Manual of Good Pharmacovigilance Practices.

Law guaranteeing access to COVID-19 vaccines and medicines: Law No. 31091 published provisions guaranteeing access to preventive and curative treatment of SARS-COV-2 coronavirus disease and other diseases giving rise to national health emergencies and other pandemics declared by the World Health Organization. The main provisions are:

– Medicines and vaccines are considered essential to cure and prevent the coronavirus.

– Free and universal access to the acquisition, distribution and availability of medicines and vaccines of the SARS-CoV-2 coronavirus

– Conditional health registration for one year for medicines and biological products with phase III clinical trials with preliminary results.

 Click aquí to access the Law.