Nano drugs: regulation and quality control
Keywords:
Drugs; Quality control; Nanotechnology; Health SurveillanceAbstract
Introduction:The use of knowledge from nanotechnology in the pharmaceutical industry has led to the production of new drugs with their own therapeutic and toxicological characteristics. Controlled-release drugs that act directly on their action places, reducing their potential side effects, have been produced at the expense of this technology. With sizes comparable to those of biological entities and unique properties, this new class of drugs, the nanodrugs still presents some gaps that hinder its regulation. Objective: To evaluate these gaps, their impacts in the regulation and quality areas and the new regulation approaches under study. Method:A data survey was carried out in the electronic databases MEDLINE, PubMed and SCIELO, searching for original indexed articles, in Portuguese or in English, since 2002 until 2020. Relevant search terms in both languages were used (“Nanomedication”, “nanomedicine regulation”, “nanocarriers”, “nanomedicine”, “nanotechnology drugs”, “quality and safety by the procedure” and “nanomedicine health surveillance”). Results:The selected works describe the current moment of regulation and quality control of these nanoproducts, as well as highlight the problems that still require greater understanding. Conclusions:Nanotechnology applied to the formulation and manufacture of drugs is undoubtedly a great advance for health. However, there are several points that still require further development and that impact the regulatory frameworks for the registration, effectiveness and safety of these products.
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