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COMMISSION DIRECTIVE 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance).
Medicinal products for human use may only be placed on the market if a marketing authorisation has been delivered by a competent authority on the basis of an application dossier containing the results of tests and trials carried out on the products concerned.
Annex I to Directive 2001/83/EC lays down detailed scientific and technical requirements regarding the testing of medicinal products for human use against which the quality, safety and efficacy of the medicinal product should be assessed. Those detailed scientific and technical requirements should be regularly adapted to take account of scientific and technical progress.
Due to scientific and technical progress in the field of advanced therapies, as reflected in Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 ( 2 ), it is appropriate to adapt Annex I. The definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products should be updated. Moreover, detailed scientific and technical requirements should be established for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products.
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
The purpose of this guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by Helicobacter pylori (H. pylori) for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens. This guidance intends to serve as a focus for continued discussions among the Division of Special Pathogen and Transplant Products, pharmaceutical sponsors, the academic community, and the public. As the science of this indication evolves, this guidance may be revised as new information accumulates.
This guidance pertains to development of drugs for the treatment of adults with duodenal ulcers. It does not address treatment of children, or those with other conditions also associated with H. pylori, including gastric ulcers and non-ulcer dyspepsia. If sponsors are interested in pursuing an indication for the treatment of patients with other conditions associated with H. pylori infection or other endpoints not mentioned in this guidance, they are encouraged to discuss their proposals with the division. Sponsors desiring to pursue an indication for ulcers caused by clarithromycin-resistant organisms should discuss the types of data needed to support such a claim with the division early in drug development.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Posted in clinical, formulation, manufacturing, pre-clinical, regulatory
Tagged development, duodenal ulcer, helicobater pylori
This document provides guidance to industry on:
The information on the content of a proposed REMS submission (section III of this document) also applies to proposed REMS that are voluntarily submitted by applicants or holders of approved applications (see section II.A of this document).
This guidance will address REMS elements and provisions that are broadly applicable to proposed REMS and to assessments and modifications of approved REMS. Other provisions, such as those that pertain only to abbreviated new drug applications (ANDAs), or expanded information about REMS assessments and proposed modifications, will not be fully addressed, but will be the subject of future guidance.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Posted in licensing, regulatory
This reflection paper addresses specific points related to products containing autologous chondrocytes intended for the repair of lesion of cartilage of the knee not discussed in the ‘Guideline on human cell based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline. – Deadline for comments is 31st December 2009.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Posted in formulation, manufacturing, regulatory
Tagged Advanced Therapies, autologous, Cartilage repair, Cell therapy, Chondrocytes, clinical, Nonclinical, Quality
Many manufacturers have difficulty in interpreting whether or not their product would be considered a medical device within the terms of the Medical Device Directive 93/42/EEC. This guidance document has been developed to aid with some of the more common areas of confusion.
It is often assumed that because a product is considered a medical device, for example in the USA or Canada, or in Japan, that it will also be a medical device within the European definitions. This is not the case and manufacturers should always refer to the definitions of a medical device when making any borderline determinations. Any such decision will be based on the stated intended purpose of the product and its mode of action. Manufacturers should also consult the available published guidance in order to determine whether or not their product is considered a medical device within the European Union. The available guidance is listed in Appendix 1 of this document.
In general, medical devices must have a ‘medical purpose’ which is determined by the definition of a medical device. They must also act primarily in a way that is not metabolic, immunological or pharmacological. Should they function in any way that is metabolic, immunological or pharmacological, in conjunction with having a medical purpose, they are likely to come within the remit of the regulations covering medicinal products instead. Further information on the borderline with medicinal products is available – see the list at the end of this document.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Great French Coffee and is always wellcome at IDA consultants where we drink a large amount of french coffee from our espresso machine, and its always great to see a business that is close to our hart progress. For along time we have been drinking coffee from Patrick Joseph’s shop Le Cafe Shop, Patrick is the king of great coffee and imports all his stock in from France its the only place he coudl get coffee he wanted. Now he is availanble online (great coffee link http://lecafeshop.co.uk) along with French Coffee Makers, and Coffee Grinders.
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I have read a great story in First Word (Click here)
Merck & Co. and the UK charity Wellcome Trust announced Thursday the creation of a joint venture that will focus on developing affordable vaccines against diseases that commonly affect low-income countries. I don’t doubt that Merck are keen to be do good but there is a great upside that I am sure will not be lost on Merck – Priority Review Vouchers. Its a topic that we have covered a few times on this site, but if you get a technology approved for a neglected tropical disease the FDA will award you a Priority Review Voucher that you can use or sell as you see fit. The estimated value of these vouchers is put at between US$50 million and US$300 million. It looks like Merck have developed a system of producing these vouchers as quickly as possible and getting charities involved to share the cost too, somebody at Merck needs a huge bonus for this one, and think of the huge global health benefits its going to deliver.
for more article on this topic try – Click Here1 and Click Here2
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Posted in business
Tagged Merck, Neglected disease, priority review vouchers, tropical disease, Wellcome
BBC Health News