Ich Technical Agreement

The role of the JE is to promote public health by strengthening harmonization through the development of technical guidelines and pharmaceutical registration requirements. [1] The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulators and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development and registration. The 10,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000 The personal meetings of the working group are usually held only during the semi-annual meetings of the ED. Intermediate reports are produced at each assembly meeting and published on the ICH website. In almost all cases of outsourcing of BMP`s activities, there will also be a trade agreement covering outsourced activities, such as a “manufacturing and procurement agreement,” for example.B. This trade agreement is generally developed by legal and commercial development staff and does not go into detail to comply with the principles of the GMP. Step 2a will be taken if the Assembly approves, on the basis of the Working Group`s report, that there is sufficient scientific consensus on technical issues for the technical document to move to the next stage of regulatory consultation. The Assembly then approves the technical document Step 2a. The ICH guide states that “there should be a written and approved contract or formal agreement between the contractor and the contractor that sets out in detail the GMP responsibilities, including quality measures, of each party.” International Conference on harmonizing technical requirements for the registration of medicines for human use. If these two agreements contain provisions relating to the same purpose, they must be carefully considered if one of the agreements is amended at a later date. The working group is working on a draft consensus of the technical document based on the objectives set out in the concept document.

If a consensus is reached within the project working group, THE technical experts of the COLOCATION will sign the experts` churn sheet in Stage 1. The technical document of the experts of the first stage is then submitted to the Assembly to request adoption in accordance with stage 2 of the ich procedure. It is customary for the trade agreement and the quality agreement to contain provisions on the same subject, such as rights. B audit or technology transfer. It is preferable that there be no duplication and that one of the documents simply refers to the provisions of the other agreement instead of repeating or repeating the same provisions.

This entry was posted in Uncategorized. Bookmark the permalink.