REACH TECHNICAL DOCUMENTS

It was generally assumed that following the ICH 4 meeting in 1997 that International Harmonisation had reached an interim conclusion and that the future would focus on developing a Common Technical Document (CTD), to improve efficiency in documenting new medicines for regulatory purposes. However, the ICH process... 

The ICH Q8 guidance is currently being developed and is expected to reach the ICH Step 2 in November 2004. It is intended to provide guidance on the contents of Section State-of-the-the-Art Pharmaceutical Science. P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). 

Consideration of an initial draft is carried out in a technical committee, sub-committee or panel as appropriate. This initial draft may have come from one of a number of sources, for example, being based on work carried out by one of the bodies represented on the committee. When agreement is reached the document is made available as a draft British standard (DC) for public comment. Nowadays these drafts are almost all draft international standards (DIS) rather than purely British developed documents. The comments are considered by the technical committee and the amended document passed for publication or the collated comments sent to ISO. Consensus is reached through discussion and there is no formal voting. Revision of standards is by 5 year review as for ISO. 

As of April 2006, the preliminary REACH technical guidance documents (TGD) available to date relate to the risk assessment processes of REACH, such as the use of toxicological QSARs and the development of exposure scenarios [126]. 

REACH technical guidance documents (TGD) may prove instrumental for the future development of international guidance. Perhaps more importantly, substances subject to authorisation due to their persistent, bioaccumulative and toxic (PBT) characteristics will also be proposed for inclusion on the International Persistent Organic Pollutant (POP) register or other international conventions... 

However, the road towards reaching our research goals is full of challenges. On this road, many new findings are reported, many original problems are presented, and many design philosophies are discussed for the first time. Because all P2P streaming systems so far are proprietary without any public technical documentation available, the fundamental "entry... 

Risk Assessment Technical Guidance Document (a. 16), which will presumably apply to registration under REACH. The adequacy of each test can be defined by two basic elements ... 

Case The required documentation must include the undertaking of the technical report and assessment of the results of the dissolution profile employing Pharmacopeial conditions and removing samples from the medium at appropriate time points until the plateau is reached. The dissolution profile obtained must be similar to the profile of the unaltered formulation. ... 

EU (2005) Work Package 1. Development of the concept of exposure scenarios. General framework of exposure scenarios. Scoping study for technical guidance document on preparing the chemical safety report under REACH, final report. European Union, European Chemicals Bureau (REACH Implementation Project 3.2-1A Lot 1 Commission Service Contract No. 22551-2004-12 FISC ISP BE ... 

RRS = Risk-reduction strategy TGD = Technical guidance document [28] RIPs = REACH implementation projects... 

The Executive Council, which has oversight of the operations of the OPCW on behalf of the States Parties, has had substantial achievements since entry into force. However, there has been disappointment that the Executive Council has not been able to reach decisions on many important issues, including some dating back to the Paris Resolution (tasks that the Preparatory Commission was requested to resolve before entry into force) that are considered important for the effective operation of the OPCW. The unresolved issues include legal and technical ones related to industry declarations and verification. The Review Document expressed concern about these delays and urged the Executive Council to increase its momentum and strive to conclude all unresolved issues. ... 

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