AMRH Steering Committee Approves Five Additional Human Medicinal Products for Continental Listing

The African Medicines Regulatory Harmonisation (AMRH) Steering Committee has approved five additional medicinal products for Continental Listing during its 17–18 July 2025 session.

These approvals were based on rigorous scientific evaluations conducted by the Evaluation of Medicinal Products Technical Committee (EMP-TC) and the GMP Technical Committee (GMP-TC) under the AMRH Continental Pilot Procedure.

These products have now been included in the Green Book (2nd Edition: July 2025), which serves as the official continental registry of human medicinal products granted a Positive Opinion.

Newly Listed Products:

1. TRUQAP (Capivasertib): 160 mg and 200 mg tablets
   Applicant: AstraZeneca Pharmaceuticals
   Indication: For ER+/HER2– advanced or metastatic breast cancer with PIK3CA, AKT1 or PTEN mutations, in combination with fulvestrant.
2. STRENSIQ (Asfotase alfa): 40 mg/mL and 100 mg/mL injection
   Applicant: AstraZeneca Pharmaceuticals
   Indication: Enzyme replacement therapy for paediatric-onset hypophosphatasia (HPP).
3. ZINCOL: 20 mg Dispersible Tablets (Zinc Sulphate)
   Applicant: Varichem Pharmaceuticals Pvt. Ltd (Zimbabwe)
   Indication: Treatment of acute and persistent diarrhoea in children up to 10 years of age.

All products were confirmed to be manufactured at GMP-compliant facilities and meet continental’s requirements for quality, safety, and efficacy

It is recalled that the steering committee has approved five products in the first edition of Green book before months which makes the total listed products grow to be 10 products in 2nd edition.

Originally published on earapa.net