News - Focal Point Research
DRUGS
Health Canada’s Discussions on Nanotechnology
Health Canada is reviewing the use of Nanotechnology in drug products. At this time discussions have not included Natural Health Products or Cosmetics.
Health Canada requiring more detailed ingredients checks for OTC drugs
For OTC drug registrations, Health Canada is now requesting additional supporting documentation for certain non-medicinal ingredients that are commonly used in Cosmetic products and do not have any known restrictions with their use. February 2010
NATURAL HEALTH PRODUCTS
Focal Point Research obtains approval for a vitamin-enhanced drink as a Natural Health Product. April 2010
NAPRA takes Position on Unlicensed Natural Health Products (NHPs)
The National Pharmacists Association (NAPRA) has taken a position against the sale of unlicensed Natural Health Products being sold in pharmacies across the country.
Natural Health Products Directorate’s (NHPD) Information Workshop
In a Health Canada workshop held November 2009, the NHPD notified industry that they will begin to prepare a new risk-based compliance and enforcement approach for Natural Health Products (NHPs). More information is expected by Spring 2010. February 2010
QUALITY
Current Canadian Good Manufacturing Practices (GMPs)
The 2009 version of the Canadian GMPs became effective on November 8, 2009. Along with the changes to the new GMPs, Health Canada is reviewing its inspection program for importers, distributors and manufacturers.
FPR attends Pharmaceutical Science Group course on Annual Product Reviews (APR)
A member of FPR’s team attended a two day course conducted by Health Canada in Janary 2010 regarding Annual Product Reviews. With the issuance and implementation of the Canadian GMPs in Nov 2009, there is now a mandatory requirement to prepare Annual Product Reviews (APR) for drug products. The APR must contain a review of multiple aspects of drug product production. February 2010
ENVIRONMENT
New Ontario Toxic Reduction Regulations Now In Place
In an effort to help reduce pollution of toxic substances and protect the environment, regulated facilities in Ontario must meet the requirements of the Toxic Reduction Act, beginning January 1, 2010.
Environment Canada announces 350 chemicals being added to the Chemical Management Plan (CMP)
Environment Canada has begun collecting data from manufacturers and importers for an additional 350 chemicals. February 2010
2009
November 2009 Toronto, Ontario - FPR Attends latest briefings from Canada's Natural Health Products Directorate (contact us for more information)
November 2009 Toronto, Ontario - Health Canada discussions on nanotechnology (contact us for more information)