AESGP and CHPA Response to the EU-US Call for Industry Input on Regulatory Issues for Possible Future EU-US Trade Agreement

Directive 2001/83/EC

Article 10

5. In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication.

Article 74a

Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.

AGENCY: European Commission

Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.)

21 USC 355(c) and 355(j) (using parallel language for contents of new drug applications, and abbreviated new drug applications, respectively; subsection (b) language shown below)
(Waxman-Hatch Act)
[I]f an application submitted under subsection
(b) of this section for a drug, which includes
an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b) of this section, is approved after September 24, 1984, and if such application contains reports of new clinical investigations (other than bioavailability studies)
essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b) of this section for the conditions of approval of such drug in the approved subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) of this section if the investigations described in clause (A) of subsection (b)(1) of this section and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

(iv) If a supplement to an application approved
under subsection (b) of this section is
approved after September 24, 1984, and the supplement contains reports of new clinical investigations (other than bioavailabilty 1 studies)
essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b) of this section for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b) of this section if the investigations described in clause (A) of subsection (b)(1) of this section and relied upon by the applicant for approval of the application were
not conducted by or for the applicant and if the applicant has not obtained a right of reference
or use from the person by or for whom the investigations were conducted.

AGENCY: FDA

The principles and guidelines for GMP are stated in two Directives:

• Directive 2003/94/EC for medicines and investigational medicines for human use;
• Directive 91/412/EEC for medicines for veterinary use.

AGENCY: EMA, national competent authorities.

Basic authority for inspections is described in 21 USC 374.

AGENCY: FDA

FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with both human and non-human animal subjects

21 CFR Part 312
[Docket No. 2004N–0018]
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application

AGENCY: FDA