Lima, March 14, 2019
E-HEALTH No. 01
Life Sciences & Health Care
TECHNICAL STANDARD FOR HEALTH REGULATING MINIMUM DATA FOR IN-HOUSE ANALYTICAL TECHNIQUES VALIDATION
The Ministerial Order No. 234-2019/MINSA was published in the Official Gazette “El Peruano”. This Ministerial Order approved the Technical Regulation for Health (NTS) No. 147-MINSA/2019/DIGEMID that regulates minimum data to be included in the document for in-house analytical techniques validation.
This regulation shall be mandatory for requests of registration, reregistration, and health registry amendment submitted as of the effective day.
The regulation shall come into force this September.
Click here to view the document:
TECHNICAL DOCUMENT FOR HEALTHY FOOD PROMOTION AND PROTECTION
On Saturday, March 2, the Ministerial Order No. 195-2019/MINSA was published in the Official Gazette “El Peruano”. This Ministerial Order approved the Technical Document: Guidelines for Healthy Food Promotion and Protection in Public and Private Schools of Basic Education System.
The purpose of this document is to promote and protect healthy food for children and adolescents of public and private schools of Basic Education System.
Some general aspects are provided for as follows:
The regulation sets aside the Ministerial Order No. 161-2015/MINSA, Health Directive for Promotion of Healthy Stands and Dining Halls in Schools.
Click here to view the document:
https://cdn.www.gob.pe/uploads/document/file/296301/RM_N__195-2019-MINSA.PDF
NEW EXECUTIVE DIRECTORS IN THE GENERAL MEDICINE, SUPPLIES AND DRUG ADMINISTRATION (DIGEMID)
By virtue of Ministerial Order No. 236-2019/MINSA published in the Official Gazette “El Peruano”, the resignations of Executive Directors are accepted and new Executive Directors are appointed for the following departments of the General Medicine, Supplies and Drug Administration (DIGEMID):
Department | New Officer | Former Officer |
Department of Pharmaceutical Products | Sandra Del Pilar González Arana, Chemist | Ana Gabriela Silva Flor De Olórtegui, Chemist |
Department of Medical Devices and Health Products | Lida Esther Hildebrandt Pinedo, Chemist | Julio Américo Salas Carnero, Chemist |
Department of Inspection and Certification | Marisa Angélica Papen Bernaola, Chemist | Eldey Mary Acuña Morillo, Chemist |
Department of Pharmacovigilance, Access and Use | Maruja Crisante Núñez, Chemist | Yvonne Magali Llatas Gonzáles, Chemist |
Click here to view the document:
DOMESTIC DONATIONS
As per online communication on its webpage, DIGEMID establishes that donations of pharmaceutical products, medical devices and health products must be in compliance with requirements of the recipient entity. Donations must meet the following items:
Click here to view the communication:
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2019/C06_2019-02-25.pdf
NEW EXTRAORDINARY IMPORT AUTHORIZATION FORM
DIGEMID communicated on its webpage the new version form of Extraordinary Pharmaceutical Products Import Authorization for Prevention and Individual Treatment. Forms are available as of February 27 and its application as of this February 28.
Click here to view the communication:
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2019/C08_2019-02-28.pdf
NEW FDA REGULATION FOR SUNSCREENS
As per online press release, FDA communicated the new regulation updating control requirements for most of sun protection products in the United States.
By virtue of its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements.
Among the most outstanding proposals, the regulation:
Proposes that, of the 16 currently marketed active ingredients, two ingredients – zinc oxide and titanium dioxide – are generally recognized as safe and effective for use in sunscreens; two ingredients – para-aminobenzoic acid and trolamine salicylate – are not generally recognized as safe and effective due to safety issues.
Proposes to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+.
Proposes to require sunscreens with an SPF value of 15 or higher to also provide broad spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases.
Click here to view:
https://www.fda.gov/NewsEvents/Newsroom/ComunicadosdePrensa/ucm631930.htm