Regulatory Affairs Journal

Founded in 1990, The Regulatory Affairs Journal (RAJ) has established an international reputation as the primary source of regulatory intelligence, news and opinion for the pharmaceutical industry and regulatory agencies, worldwide.

Contents for September 2001:

• Features
• Worldwide Update Headlines
• Reference

Review 2001: Reform of EU Pharmaceutical Legislation
Pricing of Medicinal Products in Brazil
Progress on the Electronic Common Technical Document
US Prescription Drug Labelling
Vietnam: a Regulatory Overview

Argentina
ANMAT scheduling decisions on dehydroethorphine, pemoline

Australia
(S)-S-adenosylmethionine; ademetionine listing
ADRAC bulletin
Aristolochia alert
Head lice treatment review
Human gene therapy proposals

Bulgaria
New industry association

Canada
CTD implementation
Famotidine safety alert
Health Canada ADR newsletter
Nefazodone warning notice to consumers
Steroid contraceptives: draft guidance

Czech Republic
Qualified persons: information for manufacturers

EU
Certificates for medicinal products
COMP 15th meeting report
CPMP 73rd meeting highlights
CPMP procedures: oral explanations
CVMP 68th meeting report
EFPIA new publication
EMEA status report
MRLs for veterinary medicines
Notice to Applicants: updates

Germany
Pharmacovigilance: opposition to EC law rejected

Greece
EC takes Greece to ECJ over import charges

International
Cerivastatin: implications of withdrawal
Chemical safety database available on Internet
CIOMS Working Group V: pharmacovigilance
WHO new campaign on influenza

Ireland
Paracetamol pack size restriction and labelling requirements
Veterinary product transfer forms on Internet

Israel
Advertising medicinal products: extensions of approval
Product recall guidelines updated

Italy
Bilingual labelling requirements amended
Clinical trials: GPs and paediatricians as investigators
Labelling amendment: storage requirements
Pricing: postponement of changes

Jordan
Re-registration of products required after five years

New Zealand
Cloning and stem cell research: information brochure
Regulation of medicines: FAQs

Poland
BSE/TSE risk and medicinal products

Spain
Post-authorisation studies: tighter controls recommended

Switzerland
Batch certificates: harmonisation
CTD implementation
Ethical review submission forms available on Internet
TSEs: certification for exported products

UK
Antimicrobial resistance: new Advisory Committee
Ethnic medicines guidance
Gene patenting: BMA calls for debate
Genetically modified animals
Malaria prophylaxis: new guidelines
Manufacturer licence requirements for NOPs
MAVIS available on-line
NICE recommendations: COXII inhibitors, topotecan, beta-interferon and glatiramer
NICE work programme
Nurse prescribing: proposal for extensions

USA
Barcodes for medication
Comfrey-containing dietary supplements: FDA requests withdrawal
DTC advertising: impact on public health
FDA review: criteria and drug approval times
Human cell gene transfer: regulatory requirements
Improving prescription drug labels
Legislation bans human cloning
Vaccine approval process outlined
Wholesale licensing and PDMA

German Federal Institute for Drugs and Medical Devices: Who's Who
Dutch Medicines Evaluation Board Annual Report: Highlights
EC Guidance Documents: Executive Summary
Meetings of Regulatory Importance