New medicinal products

Fig. 13-2. Establishing procedures for chiral new drug substances and new medicinal products containing new chiral drug substances.

The guideline on impurities in new medicinal products parallels the drug substance text, but the designated thresholds concern only degradation products. The thresholds should be applied to the product at the end of its shelf-life, as that is when the greatest level of degradation is expected to have occurred. 

GL39 Quality specifications Test Procedures and Acceptance Criteria for new Veterinary Drug Substances and New medicinal Products Chemical Substances... 

For pharmaceutical purposes, oue of the maiu problems will be to defiue the botanical origin of the different olibanum resins. Up to now, there are no scientifically current pharmaceutical monographs on olibanum, and pharmaceutical companies that want to develop new medicinal products have an urgent need of analytical methods for the botanical identihcation and quality assurance of the resins. Attempts had been made by Hahn-Deinstrop et al. [2]. 

Adverse drug reaction (ADR) In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. ... 

FIGURE 20.2. This matrix illustrates the relationship between the phases of development and types of study by objective that may he conducted during each clinical development of a new medicinal product. The shaded circles show the types of the study most usually conducted in a certain phase of development the open circles show certain types of study that may he conducted in that phase of development hut are less usual. Each circle represents an individual study. To illustrate the development of a single study, one circle is joined by a dotted line to an inset column that depicts the elements and sequence of an individual study. 

Anon., Innovation or stagnation, challenge and opportunity on the critical path to new medicinal products, March 2004. 

The development of new medicinal products for narrower indications in serious, and usually poorly understood, diseases, such as multiple... 

The legislation makes specific provision for the time between authorisation and placing on the market. In some Member States, where it is necessary to obtain approval for reimbursement, this may entail a delay of some months. During this time, where a compassionate-use programme has previously been set up, article 84.8 states that the applicant shall ensure that patients taking part also have access to the new medicinal product. ... 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

New medicinal products derived from human blood or human plasma... 

FDA s Critical Path to New Medicinal Products, also known as the Critical Path Initiative, aimed at networking clinical trials through integrative informatics... 

ICH E2A provides a definition of adverse drug reaction that is applicable during preapproval clinical experiences with a new medicinal product ... 

In general, according to EU law, applicants are expected to carry out controlled clinical trials, randomized and as appropriate against a placebo and an established medicinal product (an active comparator) of proved therapeutic value. However, applicants may justify use of other trial design. The treatment of the control groups will vary from case to case and also will depend on ethical consideration and therapeutic area. In some cases it may be more justified to compare the efficacy of a new medicinal product with that of an established medicinal product of proved therapeutic value rather than with a placebo. 

EU EUDRALEX 3BSlla Pharmacokinetics and Metabolic Studies in the Safety Evaluation of new Medicinal Products in Animals. April 1994... 

EMEA/27164/98 (1998) Rev.l Report on the experts round table on the difficulties related to the use of new medicinal products in children held on 18 December 1997 July 1998... 

The centralised procedure allows applications to be made directly to the EMEA, which are then allocated for assessment to one member state (the rapporteur) assisted by a second member state (co-rapporteur). This approach is mandatory for biotechnology products and optional for new medicinal products. 

In cases of a trial of a new combination of active substances, the requirements are equivalent to those in trials of new medicinal products. Data on the scifety and efficacy of the combination shall be attached. 

New medicinal products are protected by patent. No mechanism other than patent protection provides for marketing exclusivity. 

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