PHARMA. Core competences and services
Basics
- Database Searches and Literature Retrieval
- Biocompatibility / Preclinical / Toxicology Testing Programs
Medicinal products
- Preclinical Drug Development Testing Programs
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CTD-format Application Dossiers
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Nonclinical Overviews and Summaries (Modules 2.4/2.6);
Preclinical documentations (Module 4) -
Clinical Overviews and Summaries (Modules 2.5/2.7);
Clinical documentations (Module 5)
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Nonclinical Overviews and Summaries (Modules 2.4/2.6);
- Expert Reports on Toxicology, Efficacy and Safety
- Assessment (deficiency) Response Documents
- Risk Assessments on Excipients, Impurities or Degradation Products
- Periodic Safety Update Reports (PSURs)
Medical Devices
- e.g. Biocompatibility Evaluations according to MEDDEV
Cosmetics
- Safety Evaluations
Explanations
phase-in
Phase-in chemicals (around 100000 chemicals) are subject to the registration system in different phases over time and are defined as those meeting at least one of the following criteria:
- listed in European Inventory of Existing Commercial Chemical Substances (EINECS)
- having been manufactured in one of the current EU Member States at least once within the period of 15 years before the entry into force of REACH, but not placed on the market
- "No-Longer Polymers" placed on the market in one of the current EU Member States before REACH has entered into force
non-phase-in
Non-phase-in chemicals do not meet the criteria of phase-in chemicals. They have not been manufactured previously and need to be registered before they can be manufactured, imported or placed on the market in the EU. Non-phase-in chemicals do not benefit from the transitional regime for the registration.
Registration deadlines for pre-registered phase-in-substances:
- 1 December 2010 [> 1000 t/a; very toxic to aquatic organisms (R50-53) > 100 t/a; carcinogenic, mutagenic or toxic to reproduction (CMR) (cat 1 or 2) > 1 t/a]
- 1 June 2013 (> 100 t/a)
- 1 June 2018 (> 1 t/a)
aims of REACH
The main objectives of REACH are:
- ensurement of protection of human health and the environment
- maintenance and enhancement of the competitiveness of the EU chemicals industry increasement of transparency
- promotion of non-animal testing
- compliance with EU international obligations under the WTO
