Regulatory News


External APVMA Review Outcomes

The outcomes of an external review identifying causes for delays in approvals and registrations by the APVMA has been released.

The report highlights that a key factor influencing assessment performance is how the APVMA responds to and handles submissions of varying quality standards. For the time period under review (just over 3 years) some interesting statistics emerge:

- A total of 11,000 applications from 887 applicants.
- The top 38 applicants (frequent and good quality submissions) account for over 50% of the assessments.
- Item 7, 8 and 12 applications make up the largest group not meeting the timeframe targets.

Not surprisingly good quality submissions from frequent applicants (either from company applicants or via use of consultants) make up the majority of applications that are within timeframes.

The review makes a range of recommendations which the APVMA have announced they have accepted and will prioritise for implementation.

 Of particular interest is the attention in future on quality applications through:

- More effective use of refusals and requests for information, with poorer quality submissions.
- Encouragement for low frequency applicants to utilise the services of a consultant.
- Encouragement of Pre Application Assistance (PAA) for modular items to reduce re-categorisations.

The consultant team at De Groot Technical Services has always has a 'right first time' focus.

We aim to achieve this through a combination of:

- Disciplined project management.
- Highly qualified and experienced team.
- Quality processes and templates.
- Team input from different expertise areas.
- Back up resources.

 At De Groot Technical Services we take pride that most of our submissions are successfully assessed by the APVMA first time.




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