This Product- or Population-Specific Considerations II: Pregnant and breastfeeding women of the Good Pharmacovigilance Practice (GVP) is based mainly on the European guidelines on GVP, and it aims to provide guidance to marketing authorization holders (MAHs)/applicants for facilitating appropriate pharmacovigilance for medicinal products that may be used in pregnant or breastfeeding women.
Guidance on pharmacovigilance for the use of medicinal products in pregnancy and breastfeeding is widely acknowledged as important. Pregnant and breastfeeding women are considered special populations and there may be a potential maternal or fatal effect. In addition, it is necessary to consider this in the context of women of childbearing potential, as pregnancy may be unplanned or medication used before pregnancy is considered, thus, so the effects of the medicine on pregnancy and the need to avoid pregnancy or for pre-conception counselling may have to be considered by the prescribing physician and the patient in these contexts.
Medicines used during pregnancy specifically aims to benefit the (unborn) child are excluded; risk-benefit considerations regarding the medicine use before or during pregnancy or breastfeeding differ from other medicine use. This is because, in addition to the benefits and risks of the medicine for the woman, the potential risks to the (unborn) child also need to be considered. In the case of pregnancy, the risks to be considered include not only those from exposure to the medicine when used, but also the risks of untreated disease for the woman and the unborn child when no medicine is used. In the case of breastfeeding, the benefits of breastfeeding need to be weighed against the risks to the infant from medicine exposure through breast milk, and any effects of medicine use on breast milk production also need to be considered.
During clinical development of most medicines, pregnant and breastfeeding women are actively excluded from trials, and if pregnancy does occur during a trial, the usual procedure is to discontinue treatment and monitor the women to assess pregnancy outcomes. Consequently, safety data for pregnancy obtained in the pre-authorization phase are limited.
While safety data for pregnancy obtained in the pre-authorization phase are limited, it is important to collect data once a product is placed on the market, especially if use during pregnancy and/or breastfeeding is likely to occur. This helps to obtain a better understanding of the risks associated with such use and to identify and characterize any risks, even if no safety concerns have arisen in the pre-authorization phase. Historically, obtaining data from pregnant women on medicine use and outcomes during the post-authorization phase has been challenging. However, with the increasing feasibility of accessing data, it is becoming easier to generate knowledge on safety in this population.
Therefore, it is important to have well-documented and adequate data collection and assessment in a timely manner. This will enable patients and prescribers to have relevant information to make informed decisions about using medicine during pregnancy and breastfeeding, and to be well-informed about any uncertainties. Following guidance in this regard will help to minimize adverse outcomes during pregnancy and breastfeeding, without unnecessarily withholding useful treatment options from pregnant and breastfeeding women.
This Product- or Population-Specific Considerations II: Pregnant and breastfeeding women of the Saudi Good Pharmacovigilance Practice (GVP) aims to provide guidance to marketing authorization holders/applicants, and Saudi Food & Drug Authority for facilitating appropriate pharmacovigilance for medicinal products that may be used in pregnant or breastfeeding women.
In spontaneous reporting, the term 'adverse event' is synonym to (suspected) adverse reaction, and all congenital anomaly/birth defect are (suspected) serious adverse reactions (See GVP- VI.A.1.5 Seriousness). In this GVP Product- or Population-Specific Considerations II, the term 'pregnancy outcome' refers to the result of a pregnancy and hence may be a serious adverse reaction (see P.II.A.2.); this is different from general pharmacovigilance terminology in which the term 'outcome' refers to the result of an adverse reaction.
Considering that the general guidance on pharmacovigilance processes in Saudi Arabia is provided in SFDA-GVP Modules I to XVI, this guidance aims to integrate pharmacovigilance, including risk management and considerations for pregnant and breastfeeding women, with the applicable structures and processes for pharmacovigilance overall.