GENERAL MEDICINE, SUPPLIES AND DRUG ADMINISTRATION (DIGEMID)
REFERENCE PRODUCT LIST
By virtue of Director’s Resolution No. 366-2019/MINSA published in the Peruvian Gazette “El Peruano”, the reference product list that will be used as a comparator in therapeutic equivalence study was approved.
The products will be used as comparators in therapeutic equivalence study to ensure that drugs being marketed nationwide will meet the actual conditions of quality, safety and effectiveness by interchangeability of multisource drugs (generic), demonstrating to be therapeutic equivalent to the reference product.
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IMPLEMENTATION OF THE WORKING TABLE ON REGULATION REVIEW – MINISTRY OF HEALTH (MINSA)
By virtue of Ministerial Order No. 337-2019/MINSA dated April 12, 2019, priority concern to adopt measures for DIGEMID service quality improvement is declared.
Furthermore, a working table is formed to review and evaluate DIGEMID processes and procedures.
Within 30 days of having implemented the working group, it shall present a report containing improvement proposals regarding administrative simplification, as well as closing measures of file attention
It can be accessed by clicking here:
REGULATIONS REVIEW
DIGEMID informed on its website the start of statutory document review process in order to receive ideas and/or suggestions through a mobile application. This application is available since April 8.
On the site, there are 12 items to be reviewed. Ideas for the following regulations will be received until April 30:
It can be accessed by clicking here:
LIST OF PRODUCT NOT REQUIRING DIGEMID HEALTH REGISTRATION
DIGEMID published on its website the list of products that are not subject to a health registration.
The list consist of 941 items and the following can be noted:
The list is displayed here:
GENERAL ENVIRONMENTAL HEALTH AGENCY (DIGESA)
INQUIRIES REGARDING THE WARNING LABEL MANUAL
On April 17, the Ministry of Health published on its webpage a file containing 31 inquiries about the Warning Label Manual.
In said file, definitions are clarified as in the case of culinary preparation, reconstituted products and yoghurt. Moreover, provisions of octagonal-shaped warning labels in food will be applied to processed products from December 18, 2017.
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FOOD AND DRUG ADMINISTRATION (FDA)
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (Orange Book)
Orange Book, Edition No. 39 was published and consists of approved drug products with therapeutic equivalence evaluations.
The publication identifies pharmaceutical products approved based on safety and effectiveness according to the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The aforementioned information can be accessed by clicking here:
