It is now easier for foreign companies to join the Vietnamese pharmaceutical market, buoyed by recently-loosened business conditions regarding drug registration and imports.
Vietnam’s drug imports increased by 8.8 percent last year to US$3.7 billion
The Ministry of Health (MoH) has recently issued two new decrees – Decree No.155/2018/ND-CP and Decree No.169/2018/ND-CP, which revise a number of regulations under Decree No.54/2017/ND-CP and Decree No.36/2016/ND-CP, respectively.
Previously, with regulations stated in Decree 54 and Decree 36, drug registration and drug imports to Vietnam were among the top concerns for international pharmaceutical firms from the EU and ASEAN for years. Many complained that regulations in the decrees jammed their operations and proposed changes to these to facilitate their business.
According to Deputy Minister of Health Truong Quoc Cuong, the new Decree 155 has many positive changes towards cutting procedures, thus creating favorable conditions for businesses in tenders, drug imports, and others.
One of the important features of the move is the cut in the number of procedures in pharmaceutical imports which had caused concern among international pharmaceutical companies. In terms of licensing the import of drugs without a registration paper, the new decree requires label models and drug descriptions in the country of manufacturing or country of export, except for cases with a certificate of pharmaceutical product (CPP).
This requirement is simpler than those set out by the previous decree which asks for label models and descriptions of drugs being actively marketed in the countries producing the medicines, except for cases with the CPP.
Furthermore, importers are exempted from the Good Manufacturing Practice (GMP) certificate under Decree 155 if manufacturing facilities have been recognized to have met the GMP or the CPP. In contrast, the old decree asks importers to have the GMP certificate of all manufacturing facilities if the drugs under application to be imported were made by many units.
In regard to clinical records of proposed imported drugs, under the new legislation, importers are exempted from clinical records for the pharmaceuticals which received import license once under the procedure regulated in the decree. The exemption is allowed as long as no changes were made in relation to information about indications, dosage, and instruction for use. This is in contrast to Decree 54 where importers had to submit clinical records for proposed drugs as regulated by the MoH.
Meanwhile, the new Decree 169 also slashes some regulations in Decree 36 in line with Resolution No.01/NQ-CP on cutting business conditions, which will ease the business in trading medical equipments.
Nguyen Minh Tuan, head of the MoH’s Department of Medical Equipment and Works, said Decree 169 is to create a legal framework for the management of medical equipment in the new development period amidst increasing international integration, while meeting international norms.
Fruitful market
With the government’s new policies, it is forecast that more foreign companies will enter the Vietnamese market to cash in on the country’s growing medicine demands.
The MoH’s data showed that the country’s drug imports last year increased by 8.8 percent year-on-year to US$3.7 billion, reflecting growing local demands. Taken together, the number of imported pharmaceuticals granted with marketing authorization rose from 771 in 2016 to 758 in the 11 months of 2018.
The Vietnamese drug market has been on an optimistic growth track, with the turnover of the domestic market in 2017 estimated at US$5.2 billion, according to data from Business Monitor International. This is up about 10 percent on-year and is expected to continue double-digit growth over the next five years.
Vietnam’s drug spending per capita rose by 10.6 percent on-year to about US$53.5 in 2018, and is forecast to rise further in the near future, the MoH said.
Source: https://english.vietnamnet.vn