Author/Editor		Primožič, Stanislav; Lešnjak, Marija
Title		Dobra evaluacijska praksa (GRP): odgovornost sodobnih regulatornih organov
Translated title		Good review practice: responsibility of modern regulatory authorities
Type		članek
Source		Farm Vestn
Vol. and No.		Letnik 48, št. 1-2
Publication year		1997
Volume		str. 133-42
Language		slo
Abstract		Pharmaceutical documentation is in its substantial part aimed toward product registration process in which it is submitted to scientific and regulatory review. Ever increasing degree of innovation and competitiveness in the pharmaceutical market poses new challenges to modern regulatory authorities. While provision of clearcut legislation and presence of licensing, inspection and pricing authorities is substanctial, in a developed system, regulation and deregulation on the part of medicinal products are like two sides of a reversible chemical reaction leading to an equilibrium. Its position depends upon the conditions of the system: the more developed a system is, the more effective and rational the regulatory process including the review of documentation tends to be. For countries like Slovenia, which are in the process of association with the European Union, harmonization of pharmaceutical standards and regulation is an imperative. While basic conditions for this are already in place and operating (the Agency for medicinal Products and its working bodies within the Ministry of Health), present situation warrants further adaptation of policies and procedures with the EU authorities.
Summary		Farmacevtska dokumentacija je v veliki meri usmerjena v postopek registracije zdravila, kjer je podvržena znanstvenemu in upravnemu nadzoru. Vedno višja stopnja inovativnosti in konkurence v farmacevtskem sektorju zahteva tudi prilagoditve doktrin in postopkov sodobnih regulatornih teles. Prisotnost zakonodaje in delovanje registracijskih, inšpekcijskih in farmakoekonomskih instanc je podlaga, na kateri se vzpostavlja ravnotežje med procesom regulacije in deregulacije. Podobno kot pri reverzibilni kemični reakcji je položaj ravnotežja med obema procesoma odvisen od pogojev sistema (stroka, ekonomija, regulativa). Bolj ko je razvit sistem, učinkovitejši in racionalnejši so regulatorni procesi in zahteve na področju zdravil in z njimi priprava in vrednotenje dokumentacije. Za države, kakršna je Slovenija, ki so trenutno v procesu pridruževanja Evropski Uniji, je harmonizacija standardov in regulative na področju zdravil nujnost. osnovni pogoji za to so zagotovljeni in delujoči (Urad RS za zdravila s svojimi delovnimi telesi v sklopu Ministrstva za zdravstvo), trenutni položaj pa zahteva nove korake v smeri uskladitve postopkov in doktrin s tistim, ki veljajo v EU.
Descriptors		DRUG APPROVAL LEGISLATION, DRUG DRUG EVALUATION REGISTRIES DRUGS, INVESTIGATIONAL