Quality of Dossier is the Key to the Success of
Regulatory Submissions – Prof. Taylor
Environment, Materials, Processes & systems all effect quality-Nadeem Irfan Bukhari
Post-Pharma Summit Workshop at Karachi
KARACHI: Dr. Khalid Ahmad Sheikh, Professor of Pharmaceutical Quality and Regulations at the UCL School of Pharmacy, UK, who has over two decades of experience in academia, industry, and regulatory affairs, conducted a post-conference workshop during the 8th Pakistan Pharma Summit concluded recently. It was organized in Karachi on September 26, 2025. The event drew large participation from the pharmaceutical industry, including representatives from Marketing, Quality Assurance, Manufacturing, and Regulatory Affairs departments.
PPMA organized a Post-Pharma Summit Workshop on “Pathway to Regulated Markets: A Practical Guide for Pakistani Pharma Manufacturers” at Karachi on September 26th 2025. Sitting on the dais from (L to R) are Prof. Khalid Ahmad Sheikh Main facilitator and moderator of the workshop, Syed Farooq Bukhari,
Dr. Kaiser Waheed, Mr. Tauqeer Ul Haq Chairman PPMA and MS Sadia Special Secretary Health, Government of Sindh.
In addition to Prof. Khalid Ahmad Sheikh, other facilitators included Dr. Nadeem Irfan Bukhari from Qarshi University, Lahore. Several experts also delivered virtual presentations on various regulatory and quality-related topics.
Ms. Sadia, Special Secretary of Health, Government of Sindh, was the chief guest at the inaugural session. Addressing the workshop participants, she emphasized that Pakistan’s entry into regulated international markets is a matter of national interest. “We must pursue this goal with confidence”.
She highlighted two key benefits: the availability of high-quality drugs within Pakistan and the potential for pharmaceutical exports to drive economic growth. “We must move quickly, or risk being left behind. The government will create an enabling environment to help the industry achieve its goals. Workshops like these should become regular, meaningful, and results-oriented events,” she added.
Earlier in his welcome address, Mr. Taqueer Ul Haq, Chairman of the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), stated that the association has 285 member companies, which collectively hold an 80% market share. “Ninety percent of the medicines used in Pakistan are produced by the national pharmaceutical industry. We manufacture quality medicines at affordable prices and have continuously raised our quality standards,” he noted. He also mentioned that Pakistan currently exports pharmaceutical products worth approximately USD 500 million annually, and top exporters are recognized at the PESA Awards Summit regularly.
Dr. Kaiser Waheed, Chairman of the Organizing Committee of the Pakistan Pharma Summit, emphasized the need to meet international standards. “No institution in Pakistan is currently providing up-to-date knowledge and information on pharmaceutical developments. There are well-established guidelines from authorities like the FDA and the European Union. The question remains—why isn’t Pakistan exporting to markets like the USA and Europe, while countries like India and Bangladesh are doing so?”
Prof. Khalid Ahmad Sheikh, Prof. Irfan Nadeem, Mr. Haroon Qassim, Dr. Kaiser Waheed, Mr. Tauqeer Ul Haq Chairman PPMA and Ms. Sadia speaking at the Post Pharma Summit workshop organized by PPMA at Karachi on September 26th 2025.
He stressed that Pakistan does not have a single FDA-approved plant, whereas India has many. “We at PPMA have been conducting workshops for the past five years to find answers. Some local units are now accredited by PICS, WHO, and MHRA—but much more needs to be done.”
He encouraged professionals to take the lead in this transformation. “The industry can achieve FDA, MHRA, and WHO accreditations if professionals guide the process based on what’s best for public health.”
Mr. Haroon Qassim, Co-Chairman of the Organizing Committee, remarked that WHO accreditation adds credibility. He appreciated DRAP and government regulators for being on the right path and expressed hope that more companies would achieve international certifications soon.
Dr. Nadeem Irfan Bukhari, Dean of Pharmaceutical Sciences at Qarshi University, emphasized that patients have a right to safe, effective, and innovative medicines. He presented in-depth discussions on Quality by Design (QbD), drug development, and the various factors affecting quality—ranging from environment and materials to processes and systems.
This was followed by a joint online presentation from Dr. Fatemah Al-Salm (Kuwait) and Hissah Al-Suwaid (Saudi Arabia), who shared insights on regulatory pharmacy practices across the GCC countries. They discussed centralized registration systems for six GCC member states and highlighted their strategic goals, including price control, chronic disease management, and public safety.
They stressed that dossiers are evaluated jointly by representatives from all six GCC countries, and inspections—particularly from Saudi Arabia—can be stricter due to high accountability. The presentation also covered the classification of herbal, nutraceutical, and pharmaceutical products and emphasized that although Kuwait cannot manufacture drugs locally, it is open to international cooperation.
Participants of the Post Pharma Summit Workshop held at Karachi on September 26th 2025 photographed with Prof. Khalid Ahmed Sheikh, Prof. Nadeem Irfan, Dr. Kaiser Waheed, Mr. Haroon Qassim Chairman and Vice Chairman of the organizing committee respectively.
Prof. Taylor Keui from the UK discussed the British Pharmacopeia, MHRA registration processes, and the role of expert committees. “The quality of the dossier is crucial for successful regulatory submissions,” he emphasized.
He highlighted that expert groups, working independently of the pharmaceutical industry, ensure that medicinal products meet stringent standards. These groups collaborate with MHRA and other European agencies, contributing to international harmonization of standards.
Key areas discussed included particle size, polymorphism, dissolution profiles, sterilization methods, packaging, and dosing devices. “Dissolution must be a routine quality control measure, and the development process must follow pharmaceutical guidelines unless a valid justification is provided,” he said. He also reviewed EMA’s decision tree for sterilization and emphasized the importance of clear, justified documentation to avoid regulatory setbacks.
GMP and Regulatory Framework
Dr. Attia Hasnain delivered a comprehensive presentation on Good Manufacturing Practice (GMP) inspections based on international guidelines, particularly those by PICS. She explained the mission of PICS to harmonize GMP standards and ensure consistency in inspections.
She outlined how inspections cover Quality Control (QC) labs, document compliance, equipment validation, microbiological standards, stability testing, warehousing, and vendor qualifications.
Inspections typically last two days and involve a thorough review of workflows, contamination risks, and documentation. “All aspects—from particle size to analyst qualifications—are critically evaluated,” she noted.
Market Authorization in Europe
In the afternoon session, Dr. Khalid Ahmad Sheikh discussed regulatory procedures for obtaining market authorization in Europe. He elaborated on centralized, decentralized, mutual recognition, and national procedures, explaining their scope and legal frameworks.
“Even after MHRA approval, individual countries can raise questions. Therefore, it’s often advisable to get approval from a single country first,” he advised. He also detailed how centralized procedures apply to drugs for conditions like AIDS, cancer, and diabetes.
Marketing authorizations are typically valid for five years, with unlimited renewals upon reassessment. Dr. Sheikh noted that many Indian companies operate through Malta or the UK to gain access to the EU market, leveraging regulatory flexibility in those countries.
He further explained that countries under the Mutual Recognition Agreement (MRA)—such as Switzerland, Canada, USA, New Zealand, Japan, Finland, and the UK (post-Brexit)—share inspection reports and waive batch testing on imports. He also stressed the importance of European GMP certification and compliance with local legislation.
Artificial Intelligence in Pharma
In a video presentation, Mr. Paul Palmer, an expert in AI in manufacturing, highlighted the growing role of artificial intelligence in pharmaceutical processes. He compared AI with traditional automation and explained how AI can optimize yield, detect mechanical issues, and support predictive maintenance. It can be used in visual inspection of vials and tablets, detection of pattern anomalies in drying processes, and document consistency checks. He concluded by saying, “AI should be seen as a co-pilot, not a replacement, and it can be an affordable solution even for small companies.”
