• Wed. Sep 22nd, 2021

simone

ICH

International Council for Harmonization (ICH) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the aim of bringing together the regulatory authorities and pharmaceutical…

EMA

European Medicines Agency (EMA) Once known as the European Medicines Evaluation Agency (EMEA), the European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London.…

CHMP

Committee for Human Medicinal Products (CHMP) The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP replaced the…

CPMP

Committee for Proprietary Medicinal Products (CPMP) The former Committee for Proprietary Medicinal Products (CPMP) in May 2004 has been replaced by the Committee for Medicinal Products for Human Use (CHMP)…

Psoriasis

PSORIASIS: from greek “psōriasis”, which come from “psōra” (scab) which derive from “psân” (toscratch). GENERALITY OF PSORIASIS Psoriasis is an inflammatory T-cell mediated chronic skin disorder. It is mainly due…

Acne

GENERALITY ABOUT ACNE Acne Is a chronic polymorphic and multifactorial disease. It is chronic because it can lasts several years if untreated, and has a slow course. It is polymorphic…

Cutis Lesions

DERMATOSIS: come from greek words “cute-“ (dermis) + “-osis” (condition). This term is used  to indicate each and every skin illness. PATHOGNOMOMIC:  come from greek words “pathos-“ (pain) + “-gnosis”…

Medicinal products for pediatric use – “Pediatrics”

In 2006 the European Union adopted the Regulation of medicinal products for pediatric use, commonly called “pediatrics” (EC) number 1901/2006/CE, such regulation governs the development and the authorization of medicinal…

Biological Medicinal Products – “Biologicals”

Biologicals   A biological medicinal product, or simply called “Biological”, is a term used for drugs which derive from biological sources rather than as a result of a chemical synthesis.…

Homeopatic drugs Legislation

Homeopatic drugs   A homeopathic Drug is defined as any medicinal product prepared from substances known as homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European…

Clinical Trials in the Healthcare Legislation

Clinical Trials   For experiments conducted on humans clinical trials are subdivided into four main phases: the first phase is called “first administration phase” also known as “Human pharmacology phase”;…

What is the Abridged procedure for Patents

Abridged procedure   In directive 2001/83/EC and in Regulation (EC) No. 726/2004 are set out the conditions to forward an application for Marketing Authorization. Through pre-clinical and clinical trials, which…

Orphan Medicinal Products (OMP) – Special benefits for the SPONSOR

Orphan medicinal products   When a pharmaceutical industry is desirous in developing a medicinal product under normal condition of marketing, because of the little number of patients affected by a…

The EMA role in Europe

Role of the EMA (ex EMEA)   The European Agency for the Evaluation of Medicinal Products (EMEA) was established by Council Regulation (EEC)Number 2309/93 22 of July 1993 and it…

Guidance on International Non-proprietary Name (INN)

Guidance on International Non-proprietary Name (INN)   The International Non-proprietary Names (INN) has the aim to provide to health professionals a unique and easy to consult method to identify pharmaceutical…