Primerjava regulatornih zahtev za pridobitev dovoljenja za promet z zdravilom v Evropski uniji in izbranih drugih državah

Pekez, Laura (avtor), Vrečer, Franc (mentor)

Farmacevtska industrija velja za eno bolj reguliranih panog, kar posledično pomeni, da je pridobitev dovoljenja za promet z zdravilom v vsaki državi dolgotrajen in zapleten postopek. Od države do države se pridobitev dovoljenja za promet z zdravilom razlikuje glede na nacionalno zakonodajo in smernice. Ker razumevanje razlik v postopku pridobivanja dovoljenja za promet z zdravilom pomembno vpliva na uspeh strategije trženja posameznih izdelkov podjetja, smo se v magistrski nalogi osredotočili na pregled postopkov pridobivanja dovoljenja za promet z zdravilom, ki je predpogoj za začetek trženja zdravila na posameznem trgu. Primerjali smo regulativo zdravil na EU trgih ter na izbranih trgih Azije in Afrike (Singapur, Malezija, Savdska Arabija ter Južna Afrika), saj ob vse večji konkurenci in posledično postopnem nižanju cen zdravil na omenjenih tržiščih, postajajo ti trgi vse bolj zanimivi za farmacevtsko industrijo. V uvodu smo naredili splošen pregled zakonodaje po posameznih regijah ter njihovih delujočih pristojnih organov. V nadaljevanju smo skozi strokovno literaturo naredili pregled poteka postopkov pridobivanja dovoljenja za promet z zdravilom, ki se uporabljajo na posameznem trgu ter njihove specifične zahteve za pridobitev le-tega. Osredotočili smo se predvsem na nova vlaganja za generična zdravila, deloma tudi na obnove in spremembe tekom življenjskega cikla izdelka. Smernice in zahteve za pridobitev dovoljenja za promet za zdravilo smo primerjalno analizirali in ugotovili, da so izbrane države že zelo regulirane in imajo podobne zahteve dokumentacije, kar je pričakovano, saj v veliki meri sledijo EU predpisom in smernicam (npr. CTD/ACTD format, klasifikacija sprememb). Največje razlike se pokažejo v času pridobivanja dovoljenja za promet za zdravilo (EU ima edina natančno določeno časovnico), veljavnosti dovoljenja za promet za zdravilo (v Singapurju in Južni Afriki že ob prvi registraciji prejmemo dovoljenje za promet za zdravilo za neomejen čas) ter v označevanju zdravil (npr. Braillovo pisavo zahteva samo EU). Natančno poznavanje regulatornih postopkov ter stalno spremljanje zakonodaje nam lahko omogoči pripravo ustrezne dokumentacije in posledično pridobitev dovoljenja za promet v zastavljenem časovnem okviru.

• Jezik: Slovenski jezik
• Ključne besede: dovoljenje za promet, regulatorne zahteve, smernice
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2022
• PID: 20.500.12556/RUL-135542
• Datum objave v RUL: 18.03.2022

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Comparison of regulatory requirements for obtaining drug marketing authorisation in the European Union and selected other countries

Izvleček

The pharmaceutical industry is a considerably regulated branch, which means that obtaining marketing authorisation for medicinal products in any country is a lengthy and complex process. The process of obtaining marketing authorisation varies from country to country, depending on national legislation and guidelines. Understanding the differences in the process of obtaining marketing authorisation has a significant impact on the success of the company’s marketing strategy for an individual product; therefore, the focus of this thesis is an overview of marketing authorisation procedures, marketing authorisation being a prerequisite for marketing a product on a particular market. In the thesis, a comparison is made between medicinal product regulations on the EU markets and those on specific Asian and African markets (Singapore, Malaysia, Saudi Arabia and South Africa). The latter markets are becoming increasingly interesting for the pharmaceutical industry due to the increasing competition and a consequent gradual decline in the prices of medicinal products on these markets. In the introduction, there is a general overview of the legislation and competent authorities by individual regions. Then, the process of obtaining marketing authorisation on individual markets and the specific requirements of the markets are reviewed through expert literature. The main focus is on new submissions for generic medicinal products, partly also on renewals and variations during a product’s lifecycle. A comparative analysis of the guidelines and requirements for obtaining marketing authorisation was made and it showed that the above-mentioned Asian and African countries are already highly regulated and have similar documentation requirements, which is logical, as they largely follow EU regulations and guidelines (e.g. CTD/ACTD format, classification of variations). The biggest differences are seen in the time of obtaining marketing authorisation (a well-defined timeline only in the EU), the validity of marketing authorisation (unlimited validity of marketing authorisation already upon first registration in Singapore and South Africa) and in the labelling of medicinal products (e.g. Braille mandatory only in the EU). What is needed for appropriate documentation to be prepared and consequently marketing authorisation to be obtained within the set time frame is accurate knowledge of regulatory procedures and constant monitoring of the legislation.

• Ključne besede: marketing authorisation, regulatory requirements, guidelines