On April 3, 1996, Dann Michols, Director General, Drugs Directorate, issued a further letter on invitations to a consultation workshop to discuss issues surrounding direct-to-consumer advertising of prescription drugs. The meeting is to be held on June 18, 19, 1996 at the Chateau Cartier Hotel, Aylmer, near Ottawa. A request was made for position papers regarding concerns with respect to the issues. These will be distributed prior to the meeting and will form the basis for discussion. It was requested that 50 copies of the papers be sent to Dr. Valerie Robertson, Advertising Coordinator, Drugs Directorate, 1600 Scott Street, Holland Cross, Tower B, 4th Floor, Address Locator 3104C, Ottawa Ontario K1A 1B6.

A March 15, 1996 letter to Canadian Associations from Dann Michols included a revised Management of Drug Submissions Policy together with an attachment of Revised Performance Targets, effective January 1, 1996. The policy applies particularly to NDS, SNDS, ANDS, NC, and IND submissions, detailing management of Filings, Screening, Evaluations, Refilings and Appeals. The Progress Update,(49 pages) shows a total of 48 projects of 61 completed, with 2 having been cancelled. They include the following updates:

Psychoactive drugs: Recommendations being implemented. Complete.

RadioPharmaceuticals: Jan. 19, 1996. Transfer of division to Bureau of Biologics.

Cosmetics: Being monitored under Strategic Priority Programme on Development.

Evaluation Reports: Jan. 19, 1996 Report templates have been developed.

Electronic Submissions: Short term projects include Product monographs, the objective is to automate the submission and review process and improve quality.

Compliance: Three major components under development. The inspection and analytical strategies have been approved by management, the third, an investigation strategy, remains under development. The Branch Committee is developing Compliance Policy as well as Seizure and Enforcement Policy/Procedure documents for inspectors.

The HPB has issued draft copy of the ICH guideline for Carcinogenicity Studies of Pharmaceuticals. This draft is in advance of the formal issue after translation into French.

May 1996 saw the issue of the draft ICH guideline "Structure and Content of Clinical Study Reports" adopted by the HPB and due to become an official guideline once it is available in both official languages.

Regulatory News United States

Accompanying the issue of the new SUPAC-IR (Scale-Up and Post Approval Changes) guidance for Immediate Release products is a new draft for Semi-Solid products SUPAC-SS. Both guidances detail the requirements for addressing changes in components, composition, batch size, site change and product strength.

A new draft guidance has also been issued for the "Content and Format for Submission of Drug Products for INDs, NDAs, ANDAs, and AANDAs". It is intended to update the previous edition first published in 1987.

Copies of the draft interim guidances are available through CPCS.

International Conference on Harmonization (ICH)

In relation to the final guidelines on the quality of biotechnological products entitled "Analysis of the Expression Construct in cells Used for the Production of r-DNA Derived Protein Products" , the FDA is publishing a final guideline under the auspices of the ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use. The commentary period appears to be still open. This guideline describes the "types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant r-DNA derived proteins".

A new draft version of the ICH guidelines for "Validation of Analytical Procedures: Methodology" has been published by the FDA and is complementary to the ICH "Text on Validation of Analytical Procedures". The posted deadline for commentary was June 5, 1996.

© 1997 CPCS, Inc.