New Zealand:_ Regulation Guidelines Updates of Therapeutic Products (Manufacture of Medicines)

On 16 August 2023, MedSafe released updates on the guidelines of therapeutic products (manufacture of medicines) focusing on the addition to the list of competent authorities and example clarification on the acceptable evidence of GMP.

New Zealand approves GMP certification certified by the competent authorities under EU-NZ Mutual Recognition Agreement, certain members of PIC or PIC/S organizations. There are 7 new countries approved to be added to the list, which are:

• Bulgaria: Bulgarian Drug Agency (BDA)

• Croatia: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

• Cyprus: Pharmaceutical Services (CyPHS)

• Estonia: State Agency of Medicines (SAM)

• Latvia: State Agency of Medicines (ZVA)

• Lithuania: State Medicines Control Agency (SMCA)

• Slovenia: Agency for Medicinal Products and Medical Devices (JAZMP)

Further, MedSafe also clarifies the examples of acceptable evidence of GMP provided by the manufacturing site audited by the USFDA and the certificates published in the EUDRA database.

The stated acceptable evidence may not be an exhaustive list but acceptable. However, there are some situations that do not meet all the requirements under Table 2 (stated in the full guidelines).

MedSafe is not accepting the evidence of the GMP certification in the form of manufacturer licenses that were not issued by any recognized authorities, certification issued by pharmaceutical companies or annual registration of drug establishments (USA).

Source: New Zealand Medicines and Medical Devices Safety Authority (MedSafe)