D. whereas it is for the legislator to determine, on a case-by case basis, the level of detail of each legislative act and thereby also to decide whether to delegate any power to the Commission to adopt delegated acts as well as whether there will be any need for powers to ensure uniform conditions for implementing the legislative act; whereas the conferral of such delegated or implementing powers is never an obligation; whereas such conferral should however be considered where flexibility and efficiency are needed and cannot be delivered by means of the ordinary legislative procedure; whereas the decision as to whether to confer delegated or implementing powers must be based on objective factors which must permit ...[+++]judicial review of the solution adopted; whereas the absence of case law on Article 290 TFEU and on the criteria laid down therein has made it more difficult for the European Parliament and Council to agree on a delimitation between implementing and delegated acts;

The quality system assessment should include audits on the premises of the manufacturer and, if this is also necessary to ensure efficient control, on those of its critical subcontractors or of its crucial suppliers.

However, there is a need to set out the standards to be applied in performance and judicial audits and to define the quality control methods exactly.

Audit committees help to ensure high quality financial reporting and statutory audit as well as well functioning, effective internal control including internal audit practices.

It shall be worded so as to enable the reader to obtain a good understanding of the properties, quality, the proposed specifications and control methods, the safety, the efficacy, the advantages and disadvantages of the medicinal product.

The fundamental principles of transparency, non-discrimination, efficient administration and independent judicial control, which are included in the acquis of the WTO, will contribute, we believe, to the positive evolution of China’s economic, legal and social systems.