On May 20, ANVISA published the Public Consultation 812/2020, which proposes changes to RDC 73/16 regarding exclusively type 2 changes. Type 2 changes are related to tests, specification limits and analytical methods of control quality and stability of the active pharmaceutical ingredient and medicine.

The proposal aims to reduce the number of post-authorization type 2 protocols, classifying some changes of lesser health risk as of immediate implementation. In addition, the proposal filters the list of documents required for this type of petition, eliminating those deemed repetitive and / or superfluous.

The contribution starts on 27th May and the deadline is on 10th October. Check below the main points of change brought by the new CP:

• Adjust the list of documents necessary for type 2 changes, removing repeated items directed to specific subjects and contemplating a synthetic list applicable to various types of changes.

• a – Inclusion of tests or non-critical methods: new subject resulting from the merger of two items previously titled “Inclusion of new test” and “Inclusion of complementary method”. The classification of these changes as minor and HMP procedure was maintained, making it clear that the change should not be due to unexpected events in production, results out of specification in the stability study or obligation assumed in the Term of Commitment. Still on the inclusion of methods or tests, a new subject was inserted as h. Inclusion of tests or critical methods and for this type of petition, a favorable opinion from Anvisa should be awaited

• b – Exclusion of tests or non-critical methods: new description of the subject previously titled “Exclusion of an obsolete test or method” did not allow immediate implementation, even for tests or methods considered obsolete for the product. With the new proposal, tests and non-critical methods have their place and can be implemented immediately, through individual protocol. For the tests and methods considered critical, a new subject was inserted as i. Exclusion of tests or critical methods and for this type of petition, a favorable opinion from Anvisa must be awaited.

• h – Inclusion of tests or critical methods: Still on the inclusion of methods or tests, a new subject was inserted. For this type of petition, the change can be implemented immediately and requires individual protocol.

• i – Exclusion of tests or critical methods: As for tests and methods considered critical, a new subject was inserted and for this type of petition, a favorable opinion from Anvisa should be awaited.

• c – Changes to acceptance limits within previously approved limits & d. Changes in acceptance limits outside previously approved limits: the proposal brings a new concept for changes in specifications, previously limited to narrowing and expansion. With the new standard, these changes amplify the possibilities of a smaller framework, bringing the concept of specification adjustment inside or outside the approved limit. Therefore, if the specification is adjusted within the previously approved limit, approval by Anvisa is not necessary, even if this change involves an expansion of the range.

• e – Minor changes in analytical methods: this subject has not been renamed, however the removal of the phrase “Refers to changes made by the manufacturer of the drug” in the conditions of this change made it possible to merge with the subject “h. changes made by the manufacturer of the IFA ”described in RDC 73 in force today that with the new proposal would be excluded. In other words, the new proposal brings adjustments to the documentation and the framework for changing the method now has the same criteria for drug manufacturers and IFA manufacturers.

• f – Intermediate changes in analytical methods: new subject brought up by the CP allowing immediate implementation after protocol if the conditions described below are met.

  1. Separation and detection techniques are similar, such as reverse phase liquid chromatography separation and ultraviolet spectroscopy detection.

  2. The acceptance criteria for the validation of the approved method may also apply to the proposed method.

  3. The proposed method is equivalent or better than the approved one;

  4. The results obtained with the proposed method are equivalent to those obtained with the approved method.

  5. The change does not result in approval of lots that would be disapproved by the previous method.

  6. The change does not require toxicological data. The change resulting from a compendial update, or due to the full adoption of a compendium recognized by ANVISA, also applies, even if it does not comply with the previous conditions. It does not apply to biological, immunological or immunochemical methods or changes to models of multivariate methods.

• g – Major changes in analytical methods: the major change becomes one that does not fit into the minor and intermediate. Another news for the major change is the possibility of alteration concomitant with changes in specification limits.

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