Apr. 21 – Canada: 3 New NHPD Monographs and April Communiqué

From the Natural Health Products Directorate – three new monographs:

As well, the NHPD Monthly Communiqué has been released and includes the following:

Activity Units (Potency) Required for Enzymes

Applicants seeking authorization to market enzymes are now required to submit enzyme activity units (potency) in their product licence applications (PLAs). The rationale for this requirement is that a metric quantity (i.e. grams) is insufficient for determining the amount of enzyme present since purity is often low and a proportion of the enzyme may be inactive or partially active or cofactors/stabilizers may be present.