Global Regulatory Intelligence
Log in |  Register

Login to your account

Username *
Password *
Remember Me

Create an account

Registering to our Regulatory Updates easy andis should only
take few minutes. To begin, enter your email enter your email
address below so we can check to see if it is already existing
in our records. Your email address will also be used as your
user name when you log in.

Fields marked with an asterisk (*) are required.
Name *
Username *
Password *
Verify password *
Email *
Verify email *
Captcha *
Reload Captcha

New Zealand: MEDSAFE Updated Guidance on Pharmacovigilance

Wednesday, December 20, 2017: The New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) has updated guidelines on pharmacovigilance for collecting and evaluating information relevant to the benefits and risks of harm of approved medicines.

Before a medicine is marketed any experience of its safety and efficacy is limited to its use in clinical trials. However clinical trials do not always reflect the actual use of a medicine or vaccine in real life. For example, a medicine may only have been tested in a relatively small number of people for a limited length of time.

Although Medsafe may receive extensive information from clinical trials for a specific medicine, some adverse reactions are rare and may not be seen until a very large number of people have taken the medicine. For this reason, it is very important to monitor all medicines after they have been approved.

Pharmacovigilance involves:

  • monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects
  • assessing the risks and benefits of medicines to determine if action is required to improve their safe use
  • providing information to healthcare professionals and consumers to promote the safe use of medicines
  • monitoring the impact of any action taken and assessing whether further action is required.

Information from many sources is used for pharmacovigilance, including:

  • clinical and observational studies
  • published medical literature
  • pharmaceutical companies
  • other regulatory authorities such as the FDA (USA), EMA (Europe) and TGA (Australia)
  • spontaneous suspected adverse reaction reports submitted to the Centre for Adverse Reactions Monitoring (CARM)

The main aim of pharmacovigilance is to identity signals of a possible problem.

More Details
© 2016 MakroCare. All Rights Reserved.
  Privacy policy