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CNAA / Theses / 2005 / July /

Studies regarding the improvement of drug registration process


Author: Liliana Rusnac
Degree:doctor of pharmacy
Speciality: 15.00.01 - Pharmacy
Year:2005
Scientific adviser: Vladimir Safta
doctor habilitat, professor, State University of Medicine and Pharmacy "Nicolae Testemitanu"
Scientific consultant: Boris Parii
doctor habilitat, professor, State University of Medicine and Pharmacy "Nicolae Testemitanu"
Institution: National Institute of Pharmacy
Scientific council:

Status

The thesis was presented on the 6 July, 2005
Approved by NCAA on the 22 September, 2005

Abstract

Adobe PDF document0.73 Mb / in romanian

Thesis

CZU 615.1+614.275+614.35+615.452

Adobe PDF document 11.06 Mb / in romanian
252 pages


Keywords

pharmacy, management, drug, registration, licensing, managerial process, tariff, fees, medicinal products, preparations, time frame, regulation, postmarketing variations, registration certificate, drug regulatory authorities, vegetal medicinal products, homeopathic products, common technical document, certificate of pharmaceutical product, marketing authorization, manufacturing license

Summary

The comparative evaluation of drug registration evolution revealed the main stages of marketing authorization subsystem establishment in Republic of Moldova and other countries. The impact factors on drug registration were studied, their influence evaluated and priority set.

The evolution of basic functions of marketing authorization process: registration fees, structures, timeframes for processing of applications, requirements on the data to be submitted, etc. during 10 years revealed a positive dynamics, which attests to better efficiency of authorization activity.

The versatile analysis of registrations dynamics on the basis of: countries and manufacturers, ATC classification, INN and corresponding trade names, essential drugs, domestic registrations etc. was conducted. The obtained results stressed some particular features of the process.

The best choice for Drug Regulatory Authorities site was pointed - within a technically and managerially independent organization that reports to the Minister of Health and Social Welfare.

The calculation algorithm for registration fees was elaborated. As result the real fees for groups of products were determined, taking into account the work that the application generates and adjusted to achieve the goals of national drug policy. The annual adjustment of registration fees to the expenditures generated by the marketing authorization process is necessary because of incremental rate of expenses 11,2% in 2003 and 35,2% in 2004.

A timeframes study for processing of application in Republic of Moldova was conducted and duration of all operations included in the process was established. So the timeframes for drug validation was established during 68 hours 36 minutes, for experts´ evaluation - 2 hours 24 minutes and for registration – 2 hours. Taking into account the duration of periods when “the clock stopped”: the registration fees payment, quality control, signing of ministerial order and Registration Certificates, timeframes for registration of positively evaluated drug was established for 4 month. If some additional information was requested during validation or as result of experts´ evaluation or quality control the timeframes for accomplish the registration can be prolonged until 1,5 year.

The analyses of processing variation to existing authorizations gave reason to establish timeframes for variations approval process during 1 month.

The differential regulation of vegetal medicinal products was reasoned, depending on use in medicine (well established or traditional), claimed therapeutic indications and potential risks of active principles.