Communication to industry Archives - Page 5 of 22

14 Jul Communication to Industry – SAHPRA Engagement Portal – Launch Updates (14 July)

Posted at 20:56h in

Dear Applicants, As we progress with the South African Health Products Regulatory Authority (SAHPRA) Portal implementation – we note several enquiries submitted by organisations as individual emails and escalated one by one. This unfortunate tactic has now severely bottlenecked the support desk email address, and applicants who have been...

30 Jun Communication to Industry – Variations Communication

Posted at 16:13h in

Normal submission of Type IA & IAIN, IB, II The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows: Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a...

23 Jun Regulatory Requirements for Veterinary Medical Devices (Including in-vitro Diagnostic Veterinary Medical Devices)

Posted at 11:17h in

The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 9 December 2016, provides for the regulatory oversight of veterinary medical devices including In-Vitro...

13 Jun Regulatory Information Management System – Technical Files – Website Upload

Posted at 15:04h in

The South African Health Products Regulatory Authority (SAHPRA) has issued important updates impacting the technical files located in the SAHPRA eCTD repository and found in the following location, SAHPRA eCTD....

10 Jun Communication to Industry – SAHPRA Updates Regarding the Use of Yohimbine in Veterinary Medicine

Posted at 16:05h in

This communication to industry was developed to express SAHPRA’s view that the therapeutic use of yohimbine in animals may be in the public interest and to outline the steps that SAHPRA is taking to place the product in the schedules....

04 Jun SAHPRA Engagement Portal – Launch Update

Posted at 11:36h in

The South African Health Products Regulatory Authority (SAHPRA) provides the following key updates on the SAHPRA Engagement Portal....

29 May Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Posted at 22:05h in

This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....

05 May SAHPRA Engagement Portal – Variation, Renewal and Response Applications

Posted at 16:17h in

The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....

30 Apr SAHPRA Engagement Portal – Important Updates

Posted at 16:12h in

The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....

29 Apr Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)

Posted at 14:45h in

The communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies. It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt....

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