Les Médicaments

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Multiple sponsors can receive orphan drug designation for the same drug and indication; marketing exclusivity would go to the first sponsor to receive marketing approval.

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The same drug can be made available by other sponsors for different uses during the 7-year period of exclusivity. Regarding market exclusivity: A drug that is similar to another authorized orphan drug for the same rare disease indication must demonstrate clinical superiority. The FDA cannot approve the same drug for the same indication from a competitor during the period of market exclusivity unless the sponsor of the first authorized orphan product is unable to provide sufficient supply of the product, or the first sponsor provides its consent. Under this program, studies have been funded and 45 products have received market approval.

The prevalence of the condition in the EU must not be greater than 5 in 10,, or it must be unlikely that marketing the medicine would generate sufficient returns to justify the investment needed for its development. No satisfactory method of diagnosis, prevention, or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit [defined as a clinically relevant advantage or a major contribution to patient care] 78 to those affected by the condition.

A marketing authorization for another orphan product can be granted if: The original orphan product MAH consent,; or the original MAH cannot supply the product in sufficient quantity to meet demand, or the new applicant for a medicinal product similar to the authorized orphan product can demonstrate that it is safer, more effective, or otherwise clinically superior. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible morbidity or mortality or on symptoms that represent serious consequences of the disease. Priority Review status allows for a shortened review target of calendar days. Significant improvement may be demonstrated by the following examples: evidence of increased effectiveness in treatment, prevention, or diagnosis of condition; elimination or substantial reduction of a treatment-limiting drug reaction; documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or evidence of safety and effectiveness in a new subpopulation.

References Orphan Drug Act. Relevant excerpts public law , as amended : Last updated January 21 [Internet]. Silver Spring MD : U. Food and Drug Administration; Jun Human regulatory [Internet]. London: The Agency. Orphan designation; May 22 [cited Dec 4]. Rare disease policies to improve care for patients in Europe. Biochim Biophys Acta [Internet].

Rare disease and orphan drug regulation in Japan [Internet].

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In: Orphan Druganaut Blog. Orphanet [Internet]. Orphanet: about orphan drugs; Dec 3 [cited Dec 4]. Australian Government; Jun Australian Government; Aug 4. Therapeutic Goods Regulations - FC Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives. Alberta Human Services drug benefit supplement [Internet]. Edmonton: Alberta Blue Cross; Apr 1. Ontario Public Drug Programs [Internet].

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Toronto: The Ministry. Initial draft discussion document for a Canadian orphan drug regulatory framework [Internet]. Ottawa: Government of Canada; Dec Rare Diseases: understanding this public health priority [Internet].

Profile of rare diseases [Internet]. Rare diseases and orphan products: accelerating research and development. Washington DC : The Academy; Chapter 2 [cited Dec 4].

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What is a rare disease? Toronto: Canadian Organization for Rare Disorders. Medicines for rare diseases; [cited Dec 4]. Rare diseases: the bane of modern society and the quest for cures. Clin Pharmacol Ther. Toronto: CORD. Rare disease management: experiences from abroad summary. Lexington MA : Shire plc; Gupta S. Rare diseases: Canada's "research orphans". Open Med [Internet]. Intractable and rare diseases research [editorial].

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Drug development cost estimates hard to swallow. CMAJ [Internet]. The price of innovation: new estimates of drug development costs. J Health Econ [Internet]. Rare diseases, orphan drugs and their regulation: questions and misconceptions. Nat Rev Drug Discov. Drug Discov Today [Internet].

Repositionnement des médicaments

Pharma Lett [Internet]. Orphan drugs: The regulatory environment. Drug Discov Today. Designating an orphan product: drugs and biological products [Internet]. Food and Drug Administration; Aug Food and Drug Administration; Oct The future of orphan drug development.

Haffner ME. Adopting orphan drugs--two dozen years of treating rare diseases. N Engl J Med. Orphan drug product designation database [Internet]. Food and Drug Administration; - [cited Dec 4]. Figure 1. In: Orphan drugs and rare diseases. RSC Drug Discovery book Melnikova I. Rare diseases and orphan drugs. Overview of rare disease activities in Europe: part 1 [Internet]. European Commission. Community register of medicinal products [Internet].

  1. Qu'est-ce qu'un médicament ?.
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  4. praticiens ne prescrivant pas de médicaments (Loi sur les), L.R.O. 1990, chap. D.18.
  5. Integrated Regional Risk Assessment, Vol. II: Consequence Assessment of Accidental Releases.
  6. Orphan drug approvals by therapeutic area [figure] [Internet]. In: Rare diseases and orphan drugs. Nature Reviews Drug Discovery.

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    Distribution of opinions by therapeutic area from year - London: European Medicines Agency; [cited Dec 17].

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