In efforts to ensure all medicines reaching Papua New Guinea’s shores are safe, effective and meet quality standards, the government of Papua New Guinea has launched a product registration process for medicines called the marketing authorization system.
“With this system, we can properly evaluate the drugs coming into the country, and make sure our people are getting medicines which are safe and effective – improving public health outcomes for the country,” said PNG Health Secretary, Pascoe Kase, when launching the authorization system in Port Moresby today.
World Health Organization Country Office Representative in PNG, Dr Luo Dapeng, congratulated the PNG government for achieving what he said is a milestone for regulatory system strengthening which will help “improve access to safe, effective and quality medicines – which is our ultimate goal”.
The marketing authorization system will enable PNG’s National Department of Health (NDOH) to ensure that all medicines entering the country undergo registration as a mechanism to ensure the medicines are safe and effective, and sub-standard or falsified products are not brought into the country’s hospitals and pharmacies.
Secretary Kase said the system will require the support of stakeholders, particularly pharmaceutical suppliers in PNG. “For this system to really work, all pharmaceutical suppliers must have their products registered with the NDOH and they must continue to import only quality medicines that are safe and effective,” said Secretary Kase.
The event was marked with the release of the first set of Marketing Authorisation Certificates for products approved by the NDOH Pharmacy Board. The registration process involves technical pre-market product assessment to determine if the medicines meet the standards. For products to be issued this certificate or product licence, they must exhibit safety and efficacy as proven by non-clinical and clinical data. The products must meet quality requirements such as being produced in good manufacturing practice-compliant facilities and also have complete and objective product information to guide rationale and safe use.
“WHO has worked very closely with NDOH to set up this system and we will continue to support them in its implementation,” said Dr Luo. ““We should work together to ensure the integrity of pharmaceutical products. While making them available and accessible is a top priority, we must first make sure they are effective and will not harm our patients.”
The launch, which took place at the Hilton Hotel in Port Moresby, was attended by officials from NDOH, WHO, Customs, Royal Constabulary, Narcotics Control Bureau, professional societies and pharmaceutical suppliers.