REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) the principle is “one substance, one registration”. To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. During joint submission process, the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co-registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier.
When different medicinal products are produced in shared facilities, the potential for cross contamination is a concern. Hence, the presence of such contaminants should be managed according to the risk posed which in turn are related to levels that can be considered safe for all populations. PDE value represents a dose that is not expected to cause an adverse effect in an individual, even with a lifetime of exposure. This is synonymous to the term ‘Acceptable Daily Exposure (ADE)’. The derived PDE values should be well justified with expert rationale in such a way that even non-toxicologists (such as GMP inspector) are able to interpret and evaluate its content.