Principles and Practice of Pharmaceutical Medicine

to every practising physician and pharmacist in the country as one mechanism to comply with the regulation. Many of the promotio ...

The Medical Device Directive 93/42 defines medical devices and products, which combine a drug with a device. For regulatory purp ...

end of the trial, April 2003 (Brussels, ENTR/F2/BL D (2003)). EC Commission. Detailed guidance on the collection, verification a ...

Notice to applicants of the EU Commission – guideline on the categorisation of new applications versus variations applications J ...

Pharmacos 4; Directive 92/27/EC; Directive 91/ 356/EEC; Directive 87/22/EEC; Directive 97/43/; Directive 92/28/EC; Directive 89/ ...

35 Japanese Regulations 1 Etienne Labbe ́ Japan is a country of 128 million inhabitants, just a little larger than California or ...

An external bureau: the Social Insurance Agency. An advisory body: the Pharmaceutical Affairs and Food Sanitation Council (PAF ...

The Office of Drug Induced Damages, which supervises the PMDA and the administration of work related to ADRs damages. Evaluati ...

consolidated a unified organization for the regula- tion of pharmaceuticals, biologicals and medical devices, and thus now becam ...

are kept and can be used as attached data for a new drug application. 35.2 Japanese pharmaceutical laws Japanese pharmaceutical ...

Chapter 2.Pharmaceutical Affairs Council. The PAFSC is established, as well as local prefec- tures councils. Chapter 3.Pharmacie ...

juridical person. The manufacturing or import approval for a given drug is granted after ensuring that the applicant is healthy ...

Data required for a New Drug Application (NDA) According to Notification 481 from the PMSB, dated 8 April 1999, the whole origin ...

Data on local irritation. Other safety data. (e) Data on pharmacological action: Other safety data. Data on efficacy (mechani ...

Quality standards for data, facilities and functional organizations These standards cover different fields describing ‘good prac ...

in 1996. New harmonized GCP standards are now applicable to the United States, Europe and Japan as well, but they require profou ...

contract-out PMS works, and store the informa- tion records properly. ADR and Infections Reporting System are following ICH rul ...

After several revisions, including ICH agree- ments in 1993 and 1999, the present Guidelines for Toxicity Studies cover almost a ...

However, Japanese clinical trials show some dif- ferences in their organization and methodological approaches, which are still i ...

Specific guidelines. With regard to certain phar- macological or therapeutic classes, several specific guidelines have been publ ...