MC Pharma

26/12/2025

International Dossier Evaluation is the systematic, evidence-based appraisal of a Common Technical Document (CTD/eCTD) by national regulatory authorities (NRAs) to confirm the safety, efficacy and quality of a health product before approval. Harmonised guidelines from the ICH, EMA, FDA, WHO and SAHPRA increasingly promote work-sharing, reliance and electronic formats, allowing well-prepared dossiers to move faster across borders.

This article explains the principles, benefits and challenges of international dossier review and shows how MC Pharma’s regulatory team helps sponsors navigate each stage from technical gap analysis to post-approval life-cycle management.

Explore SAHPRA reliance pathways, AMA harmonisation and MC Pharma’s end-to-end regulatory services.

25/12/2025

Merry Christmas from MC Pharma!
Wishing you and your loved ones a joyful festive season filled with peace, happiness, and unforgettable moments.
Thank you for being part of our journey this year—we look forward to an amazing 2026 together!
Stay safe, stay blessed, and enjoy the magic of Christmas!

24/12/2025

Regulatory Affairs (RA) is the multidisciplinary profession that ensures medicines, vaccines, medical devices and other health products are developed, assessed, authorised and maintained in line with statutory requirements. For companies operating in, or entering, South Africa and the broader African market, a robust RA strategy is the difference between timely patient access and costly delays.

Explore SAHPRA reliance pathways, AMA harmonisation and MC Pharma’s end-to-end regulatory services.

20/12/2025

Navigating SAHPRA: A Comprehensive Guide by MC Pharma.
This guide, presented by MC Pharma, aims to provide industry professionals with a comprehensive overview of SAHPRA's structure, its core regulatory functions, its tangible impact on the market, and strategic considerations for navigating its complex landscape.

Expert guide by MC Pharma on navigating SAHPRA regulations in South Africa. Understand mandates, processes & compliance for health products.

15/12/2025

On 11 March 2025, MC Pharma completed an independent audit by Pharmalane UK Ltd. covering Good Distribution Practice (GDP) and pharmacovigilance (PV). A formal Audit Compliance Report was issued in April 2025 and the audit was officially closed following approval of MC Pharma’s responses.

Remote GDP & PV audit completed by Pharmalane UK; audit accepted and closed as an additional layer of assurance on MC Pharma’s established systems.

09/12/2025

SAHPRA warns the public about GLP-1 products sold through social media platforms. Clarence Ford spoke to Ms Coceka Ntlantla, SAHPRA regulatory compliance officer for further clarity. Views and News with Clarence Ford is the mid-morning show on CapeTalk. This 3-hour long programme shares and reflects...

08/12/2025

We are a team.
A team united by our cause, driven by our movement, and committed to making a positive impact—both within our organization and beyond.
Recently, our executive team sent two of our colleagues to the Medica 2025 Expo to explore new ways to strengthen our mission. They returned with fresh ideas, innovative opportunities, and partnerships that will help us grow and extend our reach to our country and neighboring regions.
We are proud to share that their efforts were met with enthusiasm from like-minded companies who share our vision and are eager to collaborate with South Africa through their cutting-edge solutions.
Here’s to an exciting future filled with possibilities!

20/10/2025

Happy Diwali!
May the Festival of Lights brighten your life with joy, prosperity, and peace. Wishing you and your loved ones a sparkling celebration filled with love, laughter, and light!

24/09/2025

12/09/2025

Today, 12 September 2025, South Africans and Namibians are wearing their funkiest socks in support of vulnerable children.

Supporting initiatives like Funky Socks Day aligns with MC Pharma's values of respect, equality, and responsibility to society.

09/08/2025

SmPC Compliance - Getting Product Information Right https://www.mcpharma.co.za/post/smpc-compliance

Understand SmPC compliance. MC Pharma walks you through QRD templates, SAHPRA alignment, variation types & ePI to keep your info approval-ready.