Canadian Association of Radiopharmaceutical Scientists

Dec 07, 2017: Update for MSWG FYI- Isotope Production at NTP in South Africa -- Mise à jour au sujet du réacteur NTP en Afrique du Sud

Dear MSWG Members,

This is a follow up to the November 27th message on the NTP reactor in South Africa.  Through the Association of Imaging Producers & Equipment Suppliers (AIPES), we have learned that the NTP reactor is continuing its discussion with its regulator and has not resumed production. 

At this time, the Government of Canada has been informed that Mo¬99 supply appears to be sufficient for the next 10 days.  However, there could be supply challenges during the second half of December if NTP does not promptly return to service. 

Producers and suppliers are continuing to work collaboratively during this period.  Given circumstances, it is recommended that particular attention be made to the efficient usage of medical isotopes. For your reference, a link to the Supply Management Application to Rank Uses of Technetium-99m (The “S.M.A.R.T.” Tool)  is noted here https://www.cadth.ca/SMART-Tool

The Government of Canada is monitoring the situation closely.  We will keep you informed as we receive updated information.

If you have detailed questions, please feel free to email me.

Nicole Charron

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Bonjour,

Le présent message fait suite à la communication envoyée le 27 novembre dernier au sujet du réacteur NTP en Afrique du Sud. Nous avons appris, par l’entremise de l’Association of Imaging Producers & Equipment Suppliers (AIPES), que les responsables du réacteur NTP poursuivent les pourparlers avec l’organisme de réglementation dont ils relèvent et que la production n’a pas repris.

Le gouvernement du Canada a été informé du fait que les réserves actuelles de Mo¬99 devraient être suffisantes pour les 10 prochains jours. Nous pourrions toutefois éprouver des défis au cours de la seconde moitié du mois de décembre si la production ne reprenait pas rapidement.

Les producteurs et les fournisseurs continuent de collaborer pendant cette période. Étant donné les circonstances, il est recommandé de veiller attentivement à ce que les isotopes médicaux soient utilisés de façon efficiente. À titre de référence, vous trouverez ci-après un lien vers l’outil « S.M.A.R.T. » (Supply Management Application to Rank Uses of Technetium-99m) : https://www.cadth.ca/SMART-Tool..

Le gouvernement du Canada suit la situation de près. Nous vous tiendrons informés à mesure que nous recevrons d’autres renseignements.

N’hésitez pas à m’envoyer un courriel si vous avez des questions.

Cordialement,

Nicole Charron
Office of Pharmaceuticals Management Strategies / Bureau des stratégies de gestion des pharmaceutiques
Strategic Policy Branch / Direction générale de la politique stratégique
Health Canada / Santé Canada

Dec 05, 2017

"In response to a growing concern from our membership regarding the administration of quality assurance systems in Canadian Radiopharmacy, the Canadian Association of Radiopharmaceutical Scientists has compiled a short survey to properly gauge where the differences are between organizations. The primary objective of the Association is the encouragement of radiopharmaceutical and scientific knowledge communication.  We very much look forward to your response and will communicate our findings with full transparency to foster collaboration and fairness in our industry."

https://s.surveyplanet.com/S1MnLUN-f

Dec 05, 2017

Dear Radiopharmaceutical Community,

There is currently a halt to production at NTP Radioisotopes. The Canadian Association of Radiopharmaceutical Scientists (CARS) would like to assess the impact of this production halt on the Canadian radiopharmaceutical community. Please fill out this short survey:

https://www.surveymonkey.com/r/SVKLK8C

Nov 22, 2017

Halt to production ordered at NTP Radioisotopes by TIMESLIVE

A halt to production at NTP Radioisotopes‚ a subsidiary of the South African Nuclear Energy Corporation (Necsa)‚ has been ordered after it discovered procedural deviations related to a set of standard operating protocols. Necsa‚ which is the nuclear licence holder‚ said on Wednesday that after reporting the matter to the National Nuclear Regulator (NNR)‚ it had received notification from the NNR to cease all operations in its active pharmaceutical ingredients (API) production facility at NTP with immediate effect.

South African Mo-99 plant shut after suspected hydrogen leak

CAPE TOWN (Reuters) - South Africa’s NTP Radioisotopes, one of the world’s leading producers of Molybdenum-99 used in medical diagnostic imaging, has been ordered to halt production at its Pelindaba facility after a suspected hydrogen leak

Oct 24, 2017: Fee Proposal for Drugs and Medical Devices / Proposition de frais pour les médicaments et les instruments médicaux -

On October 11th, 2017, Health Canada released its Fee Proposal for Drugs and Medical Devices. This document details the proposed ways Health Canada wishes to modernize its cost recovery regime for drugs and medical devices.

Sep 26, 2017: Radioisotope supplies stable but still vulnerable

The IAEA event examined the current supply scenario for molybdenum-99 (Mo-99) and its daughter isotope, technetium-99m (Tc-99m) and alternative production routes for the isotopes. Tc-99m is the most widely used radionuclide for medical imaging, used in more than 30 million nuclear medicine scans per year. It is extracted from Mo-99 using a Mo-99/Tc-99m generator device. Both radioisotopes have to be used quickly once they are produced, so hospitals worldwide need a constant supply of them.

Jan 18, 2017: Health Canada Notice to Stakeholders
Release of Guidance Documents for Consultation: Various good manufacturing practices and drug establishment licensing guidance documents. More information in Members Section.

Last updated:09 December 2017
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